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Showing 61–80 of 123 results

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Fluticasone Nasal Spray (Akorn) – CGMP Deviation (2023)

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIModerate

FDAApr 26, 2023Nationwide• Akorn, Inc.

Sodium Chloride Ophthalmic Solution (Akorn) – Stability Studies Discontinued (2023)

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIModerate

FDAApr 26, 2023Nationwide• Akorn, Inc.

Docu Liquid (Akorn) – CGMP Deviation (2023)

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIModerate

FDAApr 26, 2023Nationwide• Akorn, Inc.

Seatex Alcohol Sanitizer – Specification Failure (2023)

Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications

Class IIModerate

FDAApr 19, 2023FL, GA, TX• Seatex LLC

Earwax Removal System (Pharma Nobis) – Ingredient Degradation (2023)

CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.

Class IIModerate

FDAApr 6, 2023Nationwide• Pharma Nobis LLC

bioAllers Nasal Spray (Nutraceutical) – Material Discoloration (2023)

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Class IIModerate

FDAFeb 23, 2023Nationwide• Nutraceutical Corporation

MSM Nasal Spray (Pharmedica USA) – CGMP Deviation (2023)

CGMP Deviations

Class IIModerate

FDAFeb 14, 2023Nationwide• Pharmedica USA, LLC

Delsam Artificial Tears (Global Pharma) – CGMP Deviation (2023)

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

Class IIModerate

FDAJan 30, 2023Nationwide• Global Pharma Healthcare Private Limited

Artificial Tears Eye Drops (Global Pharma) – CGMP Deviation (2023)

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

Class IIModerate

FDAJan 30, 2023Nationwide• Global Pharma Healthcare Private Limited

Hand Sanitizer (Fisher) - CGMP Manufacturing Issue (2023)

CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.

Class IIModerate

FDAJan 17, 2023Nationwide• Fisher Scientific Co., LLC

Hand Sanitizer (Fisher) - CGMP Manufacturing Issue (2023)

CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.

Class IIModerate

FDAJan 17, 2023Nationwide• Fisher Scientific Co., LLC

Techni-Care Chloroxylenold (Consolidated) - CGMP Violation (2023)

CGMP Deviations: initiated due to violations of CGMP manufacturing practices

Class IIModerate

FDAJan 10, 2023Nationwide• Consolidated Chemical, Inc

Humatrix Microclysmic Gel (Consolidated) - CGMP Violation (2023)

CGMP Deviations: initiated due to violations of CGMP manufacturing practices

Class IIModerate

FDAJan 10, 2023Nationwide• Consolidated Chemical, Inc

Hand Sanitizer (Adam's Polishes) – Manufacturing Deviation (2022)

CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Class IIModerate

FDANov 5, 2022Nationwide• Adam's Polishes LLC

Olopatadine HCL Ophthalmic Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Olopatadine HCl Ophthalmic Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Artificial Tears Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

GONAK Hypromellose Ophthalmic Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Johnson's Baby First Touch Gift Set (Family Dollar) – Storage Temperature (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Midol Complete Caplets (Family Dollar) - Temperature Storage Issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

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