FDAFDA · Food and drugs·Recall number D-0756-2023
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.
Published May 31, 2023 · Recall initiated: May 8, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Distributor
- Nationwide in the USA and PR
- Lot
- Lot Numbers: AP220481, Exp 09/2024; AP220536A, Exp 10/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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