RecallDepth
Class III Terminated

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.

Company
Amneal Pharmaceuticals Of New York, Llc
Recall Initiated
May 8, 2023
Posted
May 31, 2023
Recall Number
D-0756-2023
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
69,239 vials
Firm Location
Brookhaven, NY, United States

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.

Distribution

Nationwide in the USA and PR

Lot / Code Info

Lot Numbers: AP220481, Exp 09/2024; AP220536A, Exp 10/2024

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