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Showing 921–940 of 3039 results

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Snake Gourd (Chetak) – Salmonella Risk (2025)

Product tested positive Salmonella .

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC

Ketorolac Tromethamine Eye Drops (Apotex) – sterility concern (2025)

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Class IIModerate

FDASep 5, 2025Nationwide• Apotex Corp.

Deep Indian Kitchen Quick Chili Cubes (Chetak) – Salmonella Risk (2025)

Salmonella

Product tested positive Salmonella .

Class IHigh

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC

Brimonidine/Timolol Ophthalmic Solution (Apotex) – sterility concern (2025)

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Class IIModerate

FDASep 5, 2025Nationwide• Apotex Corp.

Deep Premium Karela Ring Cut (Chetak) – Salmonella Risk (2025)

Product tested positive Salmonella .

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC

Deep Premium Tuvar Lilva Large (Chetak) – Salmonella Risk (2025)

Product tested positive Salmonella .

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC

Everolimus Tablets (Endo USA) – impurity specification failure (2025)

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

FDASep 5, 2025Nationwide• Endo USA, Inc.

Ginger Garlic Cubes (Chetak) – Salmonella Risk (2025)

Product tested positive Salmonella .

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC

Red Pearl Onions (Chetak) – Salmonella Risk (2025)

Product tested positive Salmonella .

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC

Mixed Vegetables (Chetak) – Salmonella Risk (2025)

Product tested positive Salmonella .

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC

Deep Premium Green Peas (Chetak) – Salmonella Risk (2025)

Product tested positive Salmonella .

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC

Bhindi Cut Okra (Chetak) – Salmonella Risk (2025)

Product tested positive Salmonella .

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC

XERF EFFECTOR 60 (Lutronic) – Manufacturing Defects (2025)

Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.

FDASep 4, 2025Nationwide• Lutronic Corporation 219 Sowon-Ro; Deogyang Goyang Korea (the Republic of)

Basic Biopsy Tray (American Contract Systems) – Sterilization Error (2025)

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

FDASep 4, 2025Nationwide• American Contract Systems Inc.

Entecavir Tablets 1mg (Zydus) – impurity specification failure (2025)

Failed Impurity/Degradation Specifications

Class IIModerate

FDASep 4, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Fruit Cocktail (Pacific Coast) – Lead Contamination (2025)

Potential contamination with heavy metal (Lead).

Class IIModerate

FDASep 4, 2025AL, AZ, AR +24 more• Pacific Coast Producers

FemiClear Daily Bladder Strength (Organicare) – Microbial Contamination (2025)

Microbial contamination with Escherichia coli O7:K1 and E. Coli 1303.

Class IIModerate

FDASep 4, 2025IN, PR• Organicare Nature's Science, LLC

Medical Convenience Kit (American Contract Systems) – Sterilization Error (2025)

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

FDASep 4, 2025Nationwide• American Contract Systems Inc.

Burrito Bowl Blend (Good and Gather) – Undeclared Shrimp (2025)

Undeclared Allergen

Product may contain undeclared shrimp (crustacean shellfish).

Class IIModerate

FDASep 4, 2025Nationwide• ONE FROZEN, LLC

Medical Convenience Kit (American Contract Systems) – Sterilization Error (2025)

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

FDASep 4, 2025Nationwide• American Contract Systems Inc.

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