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Vasopressin Sodium Chloride (IntegraDose) – Subpotent Drug (2024)

Subpotent Drug

Class IIModerate

FDAJan 12, 2024MN• IntegraDose Compounding Services LLC

Vasostrict (Par Sterile Products) – Superpotent Drug (2024)

Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.

Class IIModerate

FDAJan 11, 2024Nationwide• Par Sterile Products LLC

Rifampin Capsules (Amerisource) – Failed Impurities (2024)

Failed Impurities/Degradation Specification.

Class IIModerate

FDAJan 11, 2024Nationwide• Amerisource Health Services LLC

Fosaprepitant Injection (BE Pharmaceuticals) – Sterility Failure (2024)

Lack of Sterility Assurance: Aseptic process simulation failure.

Class IIModerate

FDAJan 10, 2024Nationwide• BE PHARMACEUTICALS AG

Budesonide Tablets (Teva) – Failed Dissolution (2024)

Failed Dissolution Specifications

Class IIModerate

FDAJan 8, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Rifampin Capsules 150mg (Lupin) – Subpotent Drug (2024)

Subpotent Drug and Failed Impurities/Degradation Specifications

Class IIModerate

FDAJan 5, 2024Nationwide• Lupin Pharmaceuticals Inc.

Rifampin Capsules 300mg (Lupin) – Subpotent Drug (2024)

Subpotent Drug and Failed Impurities/Degradation Specifications

Class IIModerate

FDAJan 5, 2024Nationwide• Lupin Pharmaceuticals Inc.

Fluocinolone Acetonide Oil (Glenmark) – Failed Specifications (2024)

Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

Class IIModerate

FDAJan 4, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Zenzedi Tablets (Azurity) – Label Mix-up (2024)

Labeling: Label Mix-up

Class IHigh

FDAJan 4, 2024Nationwide• Azurity Pharmaceuticals, Inc.

Cefixime Suspension (Lupin) – Failed Impurities (2024)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAJan 3, 2024Nationwide• Lupin Pharmaceuticals Inc.

Tizanidine Tablets (Dr. Reddy's) – Foreign Tablets (2024)

Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.

Class IIModerate

FDAJan 2, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Vandevi Compounded Asafoetida (Kinjin Food) – undeclared wheat (2024)

Undeclared Gluten

Undeclared wheat

Class IIModerate

FDAJan 2, 2024IN• KINJIN FOOD PRIVATE LIMITED

Bupropion XL Tablets (Rising Pharma) – Foreign Tablets (2023)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDADec 29, 2023Nationwide• Rising Pharma Holding, Inc.

Methoxsalen Capsules (Strides) – Failed Dissolution (2023)

Failed Dissolution Specifications

Class IIModerate

FDADec 29, 2023Nationwide• Strides Pharma Inc.

Ibuprofen Famotidine Tablets (Ascend) – Foreign Tablet (2023)

Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.

Class IIModerate

FDADec 29, 2023Nationwide• Ascend Laboratories, LLC

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Sterility Concern (2023)

Lack of Sterility Assurance

Class IIModerate

FDADec 28, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Divalproex Sodium Extended-Release Tablets (Amneal) – Dissolution Failure (2023)

Failed dissolution specifications

Class IIModerate

FDADec 26, 2023Nationwide• Amneal Pharmaceuticals of New York, LLC

Benzonatate Capsules (Amerisource) – Superpotent Drug (2023)

Superpotent drug: Assay results were slightly above specification at the time zero point.

Class IIILow

FDADec 26, 2023Nationwide• Amerisource Health Services LLC

Robitussin Honey CF Max Non-Drowsy (Haleon) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Products

Class IHigh

FDADec 26, 2023Nationwide• Haleon US Holdings LLC

Robitussin Honey CF Max Nighttime (Haleon) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Products

Class IHigh

FDADec 26, 2023Nationwide• Haleon US Holdings LLC

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