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Showing 4461–4480 of 14329 results

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Ketorolac Injection (Fresenius Kabi) – Particulate Matter (2020)

Presence of Particulate Matter - found in reserve sample vials at the firm.

FDAApr 20, 2020Nationwide• Fresenius Kabi USA, LLC

Ceftazidime Injection (B. Braun) – Stability Specification Failure (2020)

Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.

FDAApr 18, 2020Nationwide• B. Braun Medical Inc

Semi-Sweet Chocolate Nonpareils (Wegmans) – undeclared milk (2020)

Undeclared Allergen

Product may contain undeclared milk allergen.

Class IHigh

FDAApr 18, 2020IN, MD, MA +4 more• Mellace Family Brands California Inc

Flounder Stuffed Seafood (Freedman) – multiple allergens (2020)

Undeclared Gluten

Product may contain undeclared Wheat, Soy, Eggs, and Milk

FDAApr 17, 2020TX• Freedman Food Service, Inc dba Buckhead Meat & Seafood of Houston

Queso Sauce (Whole Foods) – undeclared cashews (2020)

Undeclared Allergen

May contain undeclared cashews (tree nut)

FDAApr 16, 2020AZ• Whole Foods Market

KORE CBD Oil (Summitt Labs) – Lead Contamination (2020)

Chemical Contamination; product contains elevated levels of lead

FDAApr 15, 2020Nationwide• Summitt Labs

Finasteride Plus Capsule (MasterPharm) – Cross Contamination (2020)

Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.

FDAApr 14, 2020Nationwide• MasterPharm LLC

Dark Chocolate Coins (Lake Champlain) – undeclared milk (2020)

Undeclared Milk

Product contains undeclared milk.

FDAApr 10, 2020CA, IL, IN +3 more• Champlain Chocolate Company

Minestrone Soup (Whole Foods) – undeclared milk (2020)

Undeclared Milk

May contain undeclared milk

FDAApr 10, 2020AL, AZ, CA +30 more• Whole Foods Market

Enoki Mushrooms (H & C Food) – Listeria Contamination (2020)

Product is potentially contaminated with Listeria monocytogenes.

FDAApr 7, 2020MD, NY, VA• H & C Food Inc.

Unsalted Butter (Homestead Creamery) – Listeria Risk (2020)

Unsalted butter has potential to be contaminated with Listeria monocytogenes.

FDAApr 1, 2020IN• Homestead Creamery, Inc.

Fresh Salmon (Koi Koi Trading) – Listeria Contamination (2020)

Salmon has the potential to be contaminated with Listeria monocytogenes.

FDAMar 26, 2020CA• MIN JIANG FOOD STORE INC DBA KOI KOI TRADING

Tetracycline HCL Capsules (Avet Pharmaceuticals) – Dissolution Failure (2020)

Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

FDAMar 23, 2020Nationwide• Avet Pharmaceuticals, Inc.

Tetracycline HCL Capsules (Avet Pharmaceuticals) – Dissolution Failure (2020)

Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

FDAMar 23, 2020Nationwide• Avet Pharmaceuticals, Inc.

HUANGFUSHANZHEN Dried Mushroom (Tiffany Food) - Undeclared Sulfites (2020)

Undeclared Allergen

Product contains undeclared sulfites.

FDAMar 20, 2020CA, DE, FL +8 more• Tiffany Food Corp.

Whole Foods Vodka Sauce (Winter Gardens) - Undeclared Milk (2020)

Undeclared Allergen

The product is being recalled for undeclared allergen (Milk).

FDAMar 20, 2020AZ, CA, CT +8 more• Winter Gardens Quality Foods, Inc.

Phytonadione Injection (Dr. Reddy's) – Container Defect (2020)

Defective Container: Recall is due to breaking and shattering of ampules upon opening

FDAMar 16, 2020Nationwide• Dr. Reddy's Laboratories, Inc.

Kudzu Root (Mountain Rose) – Salmonella Contamination (2020)

Salmonella

FDAMar 16, 2020Nationwide• Mountain Rose Inc. dba Mountain Rose Herbs

Natural Remedies Active Male (Y-O Management) – undeclared drug (2020)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction

FDAMar 16, 2020GA, IN, TX• Y-O Management LLC, dba Natural Remedy Store

Mixed Greens (Chicago Indoor Garden) – E. Coli Risk (2020)

FDA sample analysis of sprouts was positive for E. coli. FDA traceback and epi associate the firms sprouts with an outbreak of E. coli.

FDAMar 12, 2020Nationwide• Chicago Indoor Garden, Inc.

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