Drug product
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.
D-0756-2023
Product summary
- Event
- Event 92249
- Status
- Terminated
- Classification
- Class III
- Quantity
- 69,239 vials
- Official record key
drug-enforcement:D-0756-2023
Official wording
Reason: 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.
Code information: Lot Numbers: AP220481, Exp 09/2024; AP220536A, Exp 10/2024
Distribution pattern: Nationwide in the USA and PR
Derived failure modes
-
Unknown
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.