AZ, CA, FL, GA, HI, IL, IN, MA, MD, MI, MN, NV, NY, OH, PA, SC, WA, WI, British Columbia (Canada)
Evanger's Hand Packed Braised Beef Chunks with Gravy; NET WT 12 OZ; Manufactured in the USA by Evanger's Dog & Cat Food Co., Inc. Markham, IL 60428
Product is potentially contaminated with the barbiturate pentobarbital.
All product manufactured between December 1, 2015 and January 14, 2017 and bearing expiration dates of December 2019 through January 2021    Second part of UPC Code:  20107
Evanger's Hand Packed Hunk of Beef Au Jus; Grain and Gluten Free; NET WT 12 OZ; Manufactured in the USA by Evanger's Dog & Cat Food Co., Inc. Markham, IL 60428
All product manufactured between December 1, 2015 and January 14, 2017 and bearing expiration dates of December 2019 through January 2021    Second part of UPC Code:  20109
Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve).    The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems.  The device features adjustable tip geometry through use of a rotating handle to deflect the catheter.  This catheter is assembled with a hemostasis valve and a sideport infusion line.  The kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.
One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
The Smallbatch brand, frozen chicken blend for dogs and cats, 2 lbs. packages are recall due to the potential to be contaminated with Salmonella.
MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD.  Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems  The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico  Foreign distribution to Bahrain, Brazil, Canada, Italy, Japan, and Netherlands
Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters   Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner.
Model Number 414-159 Catheter Diameter 1.4mm,   Model Number 417-156 Catheter Diameter 1.7mm,  and  Model Number 420-159 Catheter Diameter 2.0mm.
Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton,  Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
BTAH340; Exp. 02/19  BTAHCP0; Exp. 04/19  BTAHLW0; Exp. 06/19  BTAHLX0; Exp. 08/19  BTAHP10; Exp 08/19
Alka-Seltzer  Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effervescent Tablets, 36-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981,  UPC 016500041085
BTAHGR0; Exp. 05/19  BTAHGR1; Exp. 05/19  BTAHGR2; Exp. 05/19  BTAJ0K3; Exp. 07/19
Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981,  UPC 016500044048
Oxford/Oxbridge AFN End Cap   10 mm x 5 mm tp 12 mm x10 mm    The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
There is a material mislabeling of the AFN End Cap.
Worldwide Distribution - US Distribution to the states of : CA, FL, KY, MN, and NJ ., and to the countries of : Brazil, Iran, Kuwait, Malaysia, Singapore, South Korea, Taiwan, and Turkey
Myelotec  Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
Obstructed/blocked port from defective VGC Access Port Body component.
U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01
Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA
8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only,  Mfd by Hospira, INC, Lake Forest, IL 60045 USA,  NDC: 0409-6625-02
Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL,  For I.V. or I.M. use.  a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25).
15,034,600 10 mL multiple dose use vials
Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50
Presence of  foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Amantadine HCl Capsules, USP, 100 mg, Rx Only,  50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15
Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771,  NDC 66689-038-50
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case,  Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01
Nationwide Distribution including AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TX, VA, WA, & WV.
InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors  InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
Worldwide Distribution - US including CA, FL, MA, MN, NC, NY, OH, PA, DC;  Foreign -  Australia, and France
ROSA Brain, 3.0.0  The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Complaint of the head holder connector locking up mechanically when tightened.
SAMI'S BAKERY, Peanut Butter Cookies, Net Wt. 7oz. (196g), Packed by: Sami's Pita Bakery Inc., Tampa, FL.
SAMI'S BAKERY, Walnut Chocolate Chip Cookies, Net Wt. 7oz. (196g), Packed by: Sami's Pita Bakery Inc., Tampa, FL.
SAMI'S BAKERY, BAKLAVA WALNUT, Net Weight. 4oz (112g)., Refer questions or comments to: Sami's Bakery., Tampa, FL.
SAMI'S BAKERY, Oatmeal Raisin Cookies, Net Wt. 7oz., Refer questions or comments to: Sami's Bakery., Tampa, FL.
SAMI'S BAKERY, Date Almond Cookies, Net Wt. 7oz. (196g), Packed by: Sami's Pita Bakery Inc., Tampa, FL.
Worldwide distribution- US (Nationwide) and countries of: Canada and Sri Lanka.
OptiLITE(TM) Products for Laser Surgery, Catalog Numbers:  HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES    The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system.
It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed below. The preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet newly enacted standards.
United Natural Trading Inc. dba Woodstock Farms
The products were shipped to retailers and distributors in limited quantities throughout the United States.
The firm's supplier (of dates/apricots) found Listeria monocytogenes within their facility. As a safety precaution, the firm has recalled their products that may contain dates/apricots.
Market Basket Cape Cod Cranberry Mix 10oz.
Wholesome Pantry Cape Cod Cranberry Mix 8oz.
Natures Promise Cranberry Trail Mix 12oz.
US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.
SoftLab Software    Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20,   Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were  manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M0033PK62523001  ST 150
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30,   Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK43022001
Divalproex Sodium Delayed Release Tablets, USP,  125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01
Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
distributed in AZ, CA, ID, OR, TX, and WA.
Undeclared milk. Goose Point Steamers in 5 Clams in Butter & Garlic Sauce is recalled because label declared butter, cream, or dairy but milk is NOT declared.
Nationwide. distribution and to United Kingdom, and Ireland.
Clif Kid Zbar Protein Chocolate Chip  10-pack, 150-count, 5-pack;
Clif Builders Variety Pack Chocolate Peanut Butter and Chocolate Mint  18-count
Clif Kid Zbar Protein Chocolate Mint  10-pack, 150-count, 5-pack;
Clif Kid Zbar Protein Variety Pack  30-count
Clif Builders Chocolate Mint  12-count, 6-pack, 7-pack, Snack Size 200-count
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.
Labeling Error: Label mix-up.  Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ  08540 USA.
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Cafe Spice GCT DBA Zaika Flavors of India Inc.
Whole Foods Market Thai Shrimp Salad, Net Wt. 14 oz..  packaged  in a clear clamshell container (refrigerated)
Thai Shrimp Salad  has incorrect back label showing information for Chicken Florentine Salad
Lot Number: 11917  Expiration Date: 07.19.17
US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore
GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
There were only one customer in California
Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL  ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025
Worldwide Distribution - USA (nationwide) Distribution
Instruments may, under certain specific circumstances listed below, fail to stop when a test is initiated and no sample is present (proximity shut down fails to end test).
Blood product in which routine testing/testing performed, interpreted, or documented incorrectly, was distributed.
Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC, labeled as: a) GoodSense Magnesium Citrate Oral Solution Saline Laxative Very Low Sodium, UPC# 846036007381, NDC 50804-686-38, Distributed by: Geiss, Desitin &Dunn, Inc., Peachtree City, GA 30269; b) Premier Value Magnesium Citrate Oral Solution saline laxative very low sodium, UPC# 840986010255, NDC 68016-826-38, Distributed by: Chain Drug Consortium, Boca Raton, FL 33431; c) Swan Very Low Sodium Citroma Magnesium Citrate, UPC# 308690686383, NDC 0869-686-38, Distributed by: Vi-Jon, Smyrna, TN, 37167 ; d) ShopRite Magnesium Citrate Oral Solution Saline Laxative Low Sodium, UPC# 041190211487, NDC 41190-686-38, Distributed by: Wakefern Food Corporation, Jamesburg, NJ 08831
Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.
Black Beans Bonanza Tamales with black beans. No Dairy:
the product contains undeclared milk (in the cheese)
Worldwide Diribution - US including Tennessee; Foreign - Italy, Portugal, Spain, Switzerland, UK, and France
plate in PEEK and NE0411 screws in Ti6Al4V that are available in Locking or Non-Locking versions. The NEOVIEW411 Screw Set consists of a standard set of NE0411 screws with different lengths suitable for the implantation of a NEOVIEW9 plate for an average anatomy
The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking  screws when inserting the screw into the radius diaphysis
Planetary Herbals Ginseng Classic;  Classic Chinese Energizer  710 mg; 60 and 120 UPC 0 21078 10215 1 tablet bottles;  60 count  - UPC 0 21078 10214 4; Product code PF0214  120 count -  UPC 0 21078 10215; Product code PR0215.
36 bottles - 7 x 120 count and 29 x  60 count.
Product was inadvertently released prior to release of all QC testing. Testing had positive results for coliform growth.
Professional Complementary Health Formulas, LLC
distributed in AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, WA, and WI and in the following countries: Canada and United Kingdom
Professional Formulas Sublinqual B12 High-Potency dietary supplement, 60-count dissolvable tablet in white plastic bottles.  Adhesive label with White, black red and green print; bottle has a heat-shrink band.  UPC code  8 40851 10054 0.
Sublinqual B12 tablets are recalled because the ingredients statement declared lactose but label does not declare milk.
PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter).  The result is a potential sterile barrier breach in the display sets. These display sets are  included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
IQF White Rice ES CA, Cardboard Tote, product #4621686100.
General Mills was notified by customer of IQF noodles  found in IQF rice. The IQF noodles contain eggs and wheat.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood and Blood Products for Reprocessing
Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA  92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only,  Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60
Failed Tablet/Capsule Specification; out of specification for tablet weight
Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30
Failed Tablet/Capsule Specification: out of specification for tablet weight.