Product Safety Recalls

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Recall D-0756-2023

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.

Recall D-0756-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0756-2023
Event ID92249
DistributionNationwide in the USA and PR
Quantity69,239 vials
Recall ReasonLabeling: 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.
Drug ClassificationClass III
Drug Code Info20230531
Recall Initiation Date20230508
Report Date20230531
Classification Date20230519
Address50 Horseblock Rd
Brookhaven, NY 11719-9509
United States
Recalling FirmAmneal Pharmaceuticals of New York, LLC
Initial Notification Letter
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