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Showing 1441–1460 of 14370 results

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Phenylephrine HCl IV Bag (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Multi Vitamin Supplement (Emceta) – Incorrect magnesium content (2023)

FDA sample analysis of Natural Systems brand Multi Vitamin, 60 Tablets, found the magnesium content as 33.5% of the amount declared in label.

FDAJul 10, 2023Nationwide

• Emceta International Inc.

Norepinephrine IV Bag (SterRx) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 7, 2023Nationwide• SterRx, LLC

Norepinephrine IV Bag (SterRx) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 7, 2023Nationwide• SterRx, LLC

Norepinephrine IV Bag (SterRx) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 7, 2023Nationwide• SterRx, LLC

Norepinephrine IV Bag (SterRx) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 7, 2023Nationwide• SterRx, LLC

Loteprednol Eye Suspension (Sun Pharma) – Potency Issue (2023)

Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

FDAJul 5, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Sunitinib Capsules (Teva) – Moisture Limit Failure (2023)

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

Class IIModerate

FDAJul 5, 2023Nationwide• Teva Pharmaceuticals USA Inc

Sodium Chloride Injection (B. Braun) – Sterility Leak Risk (2023)

Lack of assurance of sterility: bags have the potential to leak.

Class IIModerate

FDAJul 5, 2023Nationwide• B. Braun Medical Inc.

Atropine Sulfate Injection (Accord) – Particulate Matter (2023)

Presence of Particulate Matter: Particulate matter identified as fiber.

Class IIModerate

FDAJul 3, 2023Nationwide• Accord Healthcare, Inc.

Bivalirudin Injection (Accord) – Particulate Matter (2023)

Presence of Particulate Matter: Particulate matter identified as fiber.

Class IIModerate

FDAJul 3, 2023Nationwide• Accord Healthcare, Inc.

Albuterol Inhaler (Cipla) – Defective Container (2023)

Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

FDAJun 27, 2023Nationwide• Cipla USA, Inc.

Amlodipine Tablets (Lupin) – Potency Failure (2023)

Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.

FDAJun 27, 2023Nationwide• Lupin Pharmaceuticals Inc.

Tizanidine Hydrochloride Tablet 4mg (Preferred Pharmaceuticals) – Stability Failure (2023)

Failed Stability Specifications

Class IIModerate

FDAJun 26, 2023Nationwide• Preferred Pharmaceuticals, Inc.

Losartan Tablets (Strides) – Foreign Substance (2023)

Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.

Class IIModerate

FDAJun 26, 2023Nationwide• Strides Pharma Inc.

Tydemy Birth Control Tablets (Lupin) – Impurity Specification Failure (2023)

Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test

FDAJun 23, 2023Nationwide• Lupin Pharmaceuticals Inc.

PANCREAZE Digestive Enzyme Capsules (Vivus) – Stability Failure (2023)

Failed Stability Specifications

FDAJun 23, 2023Nationwide• Vivus, Inc.

Tizanidine 4mg Tablets (Amerisource) – Dissolution Specifications (2023)

Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.

Class IIModerate

FDAJun 23, 2023Nationwide• Amerisource Health Services LLC

Iron Dietary Supplements (Prodigy) – Packaging issue (2023)

This recall involves Ferrous Sulfate Enteric-Coated Tablets dietary supplements containing 324 mg of ferrous sulfate (iron) in bottles of 100 tablets. "Nationwide Pharmaceutical" and its logo are printed on the top left of the bottle's label panel. The recalled bottles include lot numbers M0786, M0816, M0817 and M0818, which are printed on the bottom of the bottle.

CPSCJun 22, 2023Nationwide• Prodigy Innovation LLC, of Princeton, New Jersey

Diclofenac Sodium Topical Solution (Alembic) – Delivery System Defect (2023)

Defective Delivery System

Class IIModerate

FDAJun 22, 2023Nationwide• ALEMBIC PHARMACEUTICALS, INC.

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