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Showing 941–960 of 3363 results

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Italian Roasted Salmon Meals (Wegmans) – Listeria Contamination (2020)

Products are potentially contaminated with Listeria monocytogenes.

FDAAug 7, 2020MD, NJ, NY +3 more• Wegmans Food Markets, Inc.

Soft Shell Crab (Wegmans) – Listeria Contamination (2020)

Products are potentially contaminated with Listeria monocytogenes.

FDAAug 7, 2020MD, NJ, NY +3 more• Wegmans Food Markets, Inc.

Chicken Cutlet (Wegmans) – Listeria contamination (2020)

Listeria

Products are potentially contaminated with Listeria monocytogenes.

Class IIILow

FDAAug 7, 2020MD, NJ, NY +3 more• Wegmans Food Markets, Inc.

AIP Veggie Pizza (Wegmans) – Listeria contamination (2020)

Products are potentially contaminated with Listeria monocytogenes.

FDAAug 7, 2020MD, NJ, NY +3 more• Wegmans Food Markets, Inc.

Chicken Cutlet Meals (Wegmans) – Listeria Contamination (2020)

Products are potentially contaminated with Listeria monocytogenes.

FDAAug 7, 2020MD, NJ, NY +3 more• Wegmans Food Markets, Inc.

Crab Soft Shell Tempura (Wegmans) – Listeria contamination (2020)

Products are potentially contaminated with Listeria monocytogenes.

FDAAug 7, 2020MD, NJ, NY +3 more• Wegmans Food Markets, Inc.

Red B Potatoes (Freshouse Produce) – Listeria risk (2020)

The firm received positive Environmental sampling results for Listeria monocytogenes.

FDAAug 7, 2020IN, MD, NC +3 more• Freshouse Produce

Thick & Crunchy Tortilla Chips (My Nana's) – Premature staleness (2020)

Tortilla chips turn stale prior to expiration date.

FDAAug 6, 2020AZ, CA, CO• La Canasta Mexican Food Products, Inc.

Pain Relief Tablets (Ultra Seal) – stability specification failure (2020)

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

FDAAug 3, 2020IL, IN, TX• Ultra Seal Corporation

Headache Relief Tablets (Ultra Seal) – stability specification failure (2020)

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

FDAAug 3, 2020IL, IN, TX• Ultra Seal Corporation

Red Cross Oral Pain (Mentholatum) – labeling error (2020)

Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.

FDAJul 31, 2020Nationwide• The Mentholatum Company

Clobetasol Propionate Cream (Golden State) – Content Uniformity Issue (2020)

Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.

FDAJul 24, 2020Nationwide• Golden State Medical Supply Inc.

Leucovorin Calcium Tablets (West-Ward) – Incorrect Imprint (2020)

Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.

FDAJul 22, 2020MS, OH• West-Ward Columbus Inc

Clobetasol Propionate Cream (Taro) – Content Uniformity Issue (2020)

Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.

FDAJul 20, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

BTREX PLUS Dietary Supplement (Lopez Gonzalez) – damaged tablets (2020)

CGMP Deviations: Presence of damaged tablets

FDAJul 13, 2020PR• Lopez Gonzalez Santana Corporation

BTREX PLUS Dietary Supplement (Lopez Gonzalez) – damaged tablets (2020)

CGMP Deviations: Presence of damaged tablets

FDAJul 13, 2020PR• Lopez Gonzalez Santana Corporation

Fosaprepitant Injection (Fresenius) – Labeling Mistake (2020)

Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.

FDAJul 13, 2020Nationwide• Fresenius Kabi USA, LLC

Skin Medica Acne System (Allergan) – Potency Failure (2020)

SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

FDAJul 6, 2020Nationwide• Allergan PLC

Skin Medica Acne Treatment Lotion (Allergan) – Potency Failure (2020)

SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

FDAJul 6, 2020Nationwide• Allergan PLC

Clonazepam Orally Disintegrating Tablets (Sun Pharmaceutical) – Cross Contamination (2020)

Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

FDAJul 6, 2020Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

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