Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial ...
FDA Recall #D-0756-2023 — Class III — May 8, 2023
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.
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.
Recalling Firm
Amneal Pharmaceuticals of New York, LLC — Brookhaven, NY
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
69,239 vials
Distribution
Nationwide in the USA and PR
Code Information
Lot Numbers: AP220481, Exp 09/2024; AP220536A, Exp 10/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated