MMRF Ela Ada Jaggery, UPC: 870400000067, Frozen
approximatley 350-400 cases (total for all products)
Label states ghee, but does not declare milk.
All lot codes, with ingredient statements that do not declare the allergen, milk, on the label.
MMRF Kumbiliappam, UPC: 87040000104, Frozen
Parotta Family Pack, UPC: 8 70400 00084 5, Frozen; and Small Parotta, UPC: 870400000012, Frozen
MMRF Neyyappam, UPC: 870400000111, Frozen
ELA ADA (JACK FRUIT), UPC: 8 70400 00085 2
WHOLE WHEAT PAROTTA, UPC: 8 70400 00092 0
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Caps Labs, Farmingdale, NY, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256
Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC 53493-292-14) bottles, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d) 1000 tablets  (NDC 49489-601-10), e) Bulk (49483-601-00) bottles, Brown, Manufactured for: Time Cap Labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256
Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by: Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC 49483-600-50), and d) BULK (NDC 49483-600-00) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
New York Blood Center, Inc. dba HBVS Elmsford Donor Center
Blood and Blood Products for Reprocessing
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Widefield OCT software feature for the Spectralis HRA+OCT and variants
FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature.   FDA has asked Heidelberg Engineering to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained for this software feature.
The Widefield OCT software feature was made available on the SPECTRALIS Software US versions 6.3 to 6.8a  It is only usable with the  Widefield Objective Module  accessory and a dedicated license.
Blood product, with a low platelet count, was distributed.
Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.
Blood products, collected from a donor with a history of multiple high risk behaviors, were distributed.
Distribution was nationwide.  There was military/government distribution.  Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Botswana, Brazil, Chile, Colombia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Malaysia, Mexico, Myanmar, The Netherlands, New Caledonia, Nicaragua, Panama, Peru, Republic of the Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay.
FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit).
There is an increased risk of false positive Proteus results when the product is used with specific types of  BD BACTEC blood culture bottles.
Roche Acetaminophen assay  03255379160-HAcetaminophen (P)  20767174160- cobas c Integra AAcetaminophen150 test
Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.
The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Izzy's Ice Cream, Maple Nut, One Pint (473 ml), UPC 51115-00106.  Izzy's Ice Cream, 1100 2nd Street S., Minneapolis, MN  55415.
Izzy's is recalling Maple Nut ice cream after being notified by a supplier that they are recalling walnuts due to possible presence of undeclared peanut residue.
US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
Medtronic DxTerity(TM) Diagnostic Catheter, JL 4.0, 6F, REF DXT5JL40
Medtronic has determined that the French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has all the correct labeling, and all the other information and configuration details are correct.
The product was distributed to the following countries: Singapore, Switzerland
Quidel MicroVue Intact PTH EIA, Model 8044.  An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.
Worldwide Distribution - USA (nationwide) Distribution.
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System.  Each kit contains 1 of each size. The kit components are packaged in individual corrugated cardboard boxes. Kits are then packaged as a case pack in cardboard boxes.     This product is used for off-loading diabetic foot ulcer.
Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.
USA (nationwide) Distribution to the states of : AL, AZ, CA, FL, GA, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601    The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
Customers may receive  the incorrect size implant from what is labeled on the box.
Catalog #5545-A-301, lot code ER9WA1A, ER9WA1D, ER9WA1E  Catalog #5546-A-601, lot code ER9MA5A
Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.
Flowmeter Module (accessory to Terumo Advanced  Perfusion System 1).    Provides the interface between the flow sensor and the system.
Inaccurrate flow readings.  Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).
Decorated (iced holiday cookies sold from self service cookie displays - cookies in the shape of eggs, bunnies and chicks.  The signage by the displays do not declare egg as an ingredient of the cookies.    Cookies are received in a 9 lb. bag    Correct Ingredients: Unbleached, Unbromated Wheat Flour (Wheat flour, malted barley flour, niacin, iron, thiamin mononitrate, riboflavin, folic acid), Cane Sugar, Palm Fruit Oil, Cage Free Eggs, Vanilla, Water, cream of Tartar, Baking Soda, Corn starch, dextrose, natural flavoring.    Signs at all locations have been changed.    Cookies were sold in 9 Bay area, CA Whole Food locations.
Some decorated (iced) Easter cookies in the shapes of eggs, bunnies and chicks sold in bulk bins in 9 northern CA Whole Foods locations do not properly declare egg as an ingredient or allergen.
The products were distributed to the following US states: NY, TX, CO, UT.  The products were distributed to the following foreign countries: Switzerland.
There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
Accelerate PhenoTest BC kit, Ref #10101018.  The firm name on the label is Accelerate Diagnostics, Tucson, AZ.    A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.
TCC-EZ, Total Contact Cast System,  Model No. TCC2-4051
A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.
Worldwide Distribution - USA (nationwide) to the states of :  CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.
MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma.    The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.
A component of the kit was found to contain bacterial contamination.
MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product.  An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029.  An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
Distributed to states: AZ, CA, NC, TX, and VA.
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441).    A qualitative In Vitro Diagnostic test.
The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion.  If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
Affected products were sent to three medical facilities.  Affected product will be returned to the manufacturer for disposition.
Knee Prosthesis, Sterile, Single-Use devices    Product Usage:  The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Catalog 5521-B-300, lot code ATV7IA  Catalog 5521-B-400, lot code ATY40A
Worldwide Distribution - USA (nationwide) Distribution to the states of:  CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, PA, TN, TX, VA, WA and WI, and to the countries of : Belgium, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, Russian Federation, Spain, Switzerland, and UK.
Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M    The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.
There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.
The device was distributed to the following states: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TN, TX, WA, WI, and WV.  The device was also distributed to Puerto Rico.
Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45.  Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
Products labeled for distribution outside the United States may have been distributed to customers in the United States.
Crimson Trace Corporation laser sights.    The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.
Finished Product with a Model 25-0657 diode had power output higher than 5 mW.
Bloody Mary, Medium, Kitchen by the Sea, From the The Beach House, Net Wt. 32.oz, Low Sodium
allergen warning not listed on labels, egg, soy & wheat including sulfites
Bloody Hell Mary, HOT,  Kitchen By The Sea, From the Beach House, Net Wt. 32 oz. (.9L), Low Sodium
allergen warning not listed on labels , egg, soy and wheat including sulfites
There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand.
A  potential commingle that could result in the product in the package not matching the product on the outer label.
US Nationwide, and the following countries: Albania, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Mexico, Morocco, Myamar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan,Thailand, Turkey, United Arab Emirates, Ukraine, United Kingdom, Uruguay, Uzbekistan,Vatican City, and Vietnam.
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
Zimmer Natural Nail System Tear Drop Guide Wire  3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00
Potential failure of sterile packaging seal.
Zimmer Natural Nail System Tear Drop Guide Wire  2.4 mm Diameter, 100 cm Length; Diameter; Item Number: 47-2490-097-01
M/DN Intramedullary Fixation Humeral Guide Wire   Bullet Tip  2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
Smooth Guide Wire Bullet Tip  3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
ZMS Intramedullary Fixation Smooth Guide Wire   Bullet Tip  3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
Zimmer Natural Nail System Tear Drop Guide Wire  2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01
ZMS Intramedullary Fixation Smooth Guide Wire  2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00
Zimmer Natural Nail System Tear Drop Guide Wire  3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00
ZMS Intramedullary Fixation Smooth Guide Wire  3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00
US (Nationwide) Canada, Kuwait, Guyana, Guatemala,  Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
The product was distributed to the following states: CT, FL, GA, IN, MA, MI, NY, and TX.  The product was distributed to the following countries: Malaysia and Netherlands.
Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600    Product Usage:  The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.
16 units (21 distribution events. The product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf)
There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.
Worldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland.
Stem Extractor f/Guide Bar, Part number 03.401.072.  Instrumentation for extraction and revision of Epoca shoulder implants.
There is a potential for the connection screw of the stem extractor to break.
Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.
AdvoCare Nighttime Recovery Amino Acid and Herbal Dietary Supplement Product code, P3201
AdvoCare Muscle Strength Dietary Supplement with HMB and Suma Product code, P3221
USA (nationwide) Distribution and Internationally to Turkey.
Genesis Surgical Cassette Tapered      Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs  wobble  within the grommets in the surgical cassette.
Hinge Coupling Hoffmann LRF Catalog # 4933-0-800    Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.
The wrong parts were picked for packaging. The connecting Nuts were  packed in the packaging labeled with Hinge coupling
US Nationwide Distribution to states of: AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.
56% 1 Day Silicone Hydrogel  (-2.50), 10 pack, UV Blocking, daily disposable contact lenses     The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.
The secondary packaging is labeled with an incorrect expiration date.
clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses     The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.
clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses     The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.
56% 1 Day Silicone Hydrogel  (-4.50), 10 pack, UV Blocking, daily disposable contact lenses     The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.
Worldwide distribution - US Nationwide and the countries of  Canada, Switzerland and Japan
Flex Arm    Product Usage:  The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are connected to the Flex Arm by adapters.
Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.
Chocolate Peanut Butter Cup Ice Cream, packaged in a 16 oz. cardboard container, UPC 082086444688
Chocolate peanut butter cup ice cream has a chocolate lid on top of the container.
Stryker Instruments Div. of Stryker Corporation
US Nationwide and Ireland, Japan, South Korea, UK
T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000   Sterile personal protection garment
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100  Sterile personal protection garment
T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000   Sterile personal protection garment
T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000  Sterile personal protection garment
T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100  Sterile personal protection garment
T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000  Sterile personal protection garment
T4 Zipper Toga, Regular; Catalog number: 0400-830-000  Sterile personal protection garment
T4 Zipper Toga, X-Large; Catalog number: 0400-850-000  Sterile personal protection garment
T4 Zipper Toga (S/M); Catalog Number: 0400-810-000  Sterile personal protection garment
T4 Pullover Toga, Large; Catalog Number: 0400-760-000  Sterile personal protection garment
T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000  Sterile personal protection garment
Retailers nationwide.  No military/govt/VA/foreign consignees.
Nxtgen Botanicals, Maeng Da Kratom, Dietary Supplement, 70 capsules
NGB Corp is recalling Nxtgen Botanicals due to potential Salmonella contamination.
US Distribution to the states of : MI, CA, OK,  and Internationally to China, Canada,
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009    Used to achieve epithelial graft in the oral cavity.
The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265  Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Lots: MOR030518IJDSA, MOR030518IJDSB, MOR030518IJDSC, MOR030518IJDSD, MOR030518IJDSE BUD: 06/03/2018;
Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265  Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10
Lots: MOR022318NWDSA, MOR022318NWDSB, MOR022318NWDSC, MOR022318NWDSD, MOR022318NWDSE BUD: 05/24/2018
Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe.  8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10
Lots: HYD030118IJDSA, HYD030118IJDSB, HYD030118IJDSD, HYD030118IJDSE BUD: 05/30/2018
NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way  Weeki Wachee, FL 34613 NDC 69623-234-14.
Hot Smoked Keta Beergarden Salmon, Seabear brand, Reduced Oxygen Packaging, Net Wt. 4oz (113g). No UPC.
Products recalled due to water phase salt deviations and mislabeling of storage instructions on finished products labels
Lot #17338/17340.    Code is interepreted as follows:  ulian Date Code.   Lot: 17 =Year 2017  338 = Day (December 4th)  Pack Date is 17340, which is also in Julian Date coding.
Lot # CSCO-17339/Pack Date 17340.     Code is interpreted as follows:  CS=Cold Smoked  CO=Coho.   Julian Date Code-Lot: 17=Year 2017, 339=Day (December 5th)  Pack Date is 17340, which is also in Julian Date coding
ITALIAN ROSE GARLIC SPREAD, Gluten Free, NET WT. 35 LB (16 kg), www.italian-rose.com, Riviera Beach, FL 33404
During a FDA inspection, it was disclosed that the firm is not documenting the mixing time of the product nor is pH monitoring for each kettle/batch mixed being conducted. The product is a shelf stable garlic spread.
Direct consignees located in MS, NJ, GA, VA, FL, NH, NY, AL, NC, CT, MD, UT, & SC retail stores and restaurants via direct delivery.
Shell Eggs packaged in quantities and styles of pack (plastic and pulp cartons, flats, and boxes)
Shell eggs have the potential to be contaminated with Salmonella Braenderup.
Plant Number  P-1065;   LOT CODES with a Julian date ranged from 011 -  102;   Numerous UPCs
US distribution and on distributor in Mexico
Traditional Medinicals  organic EveryDay Detox Lemon;  Naturally Caffeine Free Herbal Tea;  16 wrapped tea bags - Herbal Supplement  NET WT .85 oz (24g)  UPC: 32917-00197
9108 cases  (6 cartons per case, 16 teabags per carton)
Vendor has determined that portions of a large raw material lot were positive for Salmonella.
Lot Number:19461 ;    Expiration Date: January 2021
Traditional Medicinals Throat Coat Lemon Echinacea;  Lemon Echinacea, Naturally Caffeine Free Herbal Tea'  16 wrapped tea bags - Herbal Supplement  NET WT 1.13 oz. (32 g)  UPC: 32917-00159
6980 cases (6 cartons per case, 16 teabags per carton)
Lot Number: 19482;    Expiration Date: January 2021
NY, NJ, CT, MD, UT, CO, SC, PA, TX and Washington D.C.
Formagere de la Brie brand, l 'Explorateur, soft ripened cheese made from pasteurized milk, product comes in a 250g (8.8 oz), clear plastic package marked with lot # on the bottom, with UPC: 3 390010 004080.
Product may be contaminated with Listeria monocytogenes.
Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-331-04, UPC 364980331043
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-330-04, UPC 364980330046
Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC 364980329200
Worldwide Distribution - US Nationwide in the states of AZ, DE, FL, GA, ID, IL, KY, MI, MO, NH, NJ, PA, RI, TX, UT and the country of Peru
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
Worldwide Distribution - USA (nationwide) and to the countries of :  Canada and Italy
Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.
Blood products, not properly tested for relevant transfusion transmitted infections, were distributed
Blood products, not properly tested for relevant transfusion transmitted infections, were distributed.
CA, CO, FL, GA, IL, IN, KS,OH,  PA, RI, TX, VT, WA, WI, and Hong Kong
Raw dog food may have the potential to be contaminated with Salmonella
Worldwide Distribution - US Nationwide in the US states of : AL, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, SC, TN, TX, UT, and VA.   The devices were distributed to the following foreign countries: UAE, Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Indonesia, Italy, Korea, Malaysia, Netherlands, Poland, Portugal, Russia, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Uganda, UK, and Vietnam.
Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560    Product Usage:  The EEA  Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST  staples and removes a circular tissue specimen. The instrument is offered in a 33mm diameter size with either 3.5mm or 4.8mm staples. The accompanying accessories comprised of an access port, anoscope, and dilator. The access port aids the insertion and removal of the anoscope and the stapler device by dilating the anal sphincter throughout the procedure. The anoscope is designed to facilitate pursestring suture application above the dentate line. It is designed with a guide and markings to assist in creating a circumferential pursestring suture at a consistent placement within the rectum. The dilator is designed to aid the initial insertion of the anoscope and port by retracting the rectal tissue. Both the anoscope and port are transparent to facilitate visualization of the anal canal. The EEA  Hemorrhoid and prolapse stapler set with DST Series  Technology has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEA  Hemorrhoid and prolapse stapler also has application in the distal alimentary tract for the creation of end-to-end and end-to-side anastomoses.
There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.
Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515    Product Usage:  The EEA  Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST  staples and removes a circular tissue specimen. The instrument is offered in a 33mm diameter size with either 3.5mm or 4.8mm staples. The accompanying accessories comprised of an access port, anoscope, and dilator. The access port aids the insertion and removal of the anoscope and the stapler device by dilating the anal sphincter throughout the procedure. The anoscope is designed to facilitate pursestring suture application above the dentate line. It is designed with a guide and markings to assist in creating a circumferential pursestring suture at a consistent placement within the rectum. The dilator is designed to aid the initial insertion of the anoscope and port by retracting the rectal tissue. Both the anoscope and port are transparent to facilitate visualization of the anal canal. The EEA  Hemorrhoid and prolapse stapler set with DST Series  Technology has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEA  Hemorrhoid and prolapse stapler also has application in the distal alimentary tract for the creation of end-to-end and end-to-side anastomoses.
Source Plasma units, not meeting product specifications, were distributed.
Source Plasma unit, not meeting product specifications, was distributed.
Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10
Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg,  100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10