Amneal Pharmaceuticals of New York, LLC: Drug Recall

Recall #D-0756-2023 · 05/08/2023

Class III: Low Risk

Recall Details

Recall Number
D-0756-2023
Classification
Class III
Product Type
Drug
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Status
Terminated
Date Initiated
05/08/2023
Location
Brookhaven, NY, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
69,239 vials

Reason for Recall

Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.

Product Description

Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Pharamceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1574-01.

Distribution Pattern

Nationwide in the USA and PR

Other Recalls by Amneal Pharmaceuticals of New York, LLC

View all recalls by Amneal Pharmaceuticals of New York, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.