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Showing 1061–1080 of 14370 results

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Hydromorphone HCl Sodium Chloride (SCA Pharmaceuticals) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Midazolam HCl Injection (SCA Pharmaceuticals) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Succinylcholine Chloride Injection (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Fentanyl Bupivacaine Solution (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Hydromorphone Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Vancomycin Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Hydromorphone Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Phenylephrine Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Phenylephrine Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Oxygen Compressed USP (Family Medical Supply) – cGMP Deviations (2023)

cGMP Deviations

Class IIModerate

FDANov 9, 2023Nationwide• Family Medical Supply Inc

SugarMD Glucose Support Capsules (SUGARMDS) – Undeclared Medication (2023)

MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide

FDANov 8, 2023Nationwide• SUGARMDS LLC

Naproxen Tablets (Glenmark) – Labeling Mix-Up (2023)

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Class IIModerate

FDANov 7, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Indomethacin Capsules (Glenmark) – Labeling Mix-Up (2023)

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Class IIModerate

FDANov 7, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Hydrocortisone Acetic Acid Otic Solution (Taro) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

FDANov 6, 2023Nationwide• Taro Pharmaceuticals Inc.

Vitrakvi Oral Solution (Bayer) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing

FDANov 6, 2023Nationwide• Bayer Healthcare Pharmaceuticals Inc.

Trospium Chloride Capsules (Padagis) – Capsule Defects (2023)

Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

Class IIModerate

FDANov 1, 2023Nationwide• Padagis US LLC

Paroxetine Tablets 40mg (Apotex) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 1, 2023Nationwide• Apotex Corp.

Paroxetine Tablets 30mg (Apotex) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 1, 2023Nationwide• Apotex Corp.

Paroxetine Tablets 10mg (Apotex) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 1, 2023Nationwide• Apotex Corp.

Paroxetine Tablets 20mg (Apotex) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 1, 2023Nationwide• Apotex Corp.

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