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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0756-2023 |
| Event ID | 92249 |
| Distribution | Nationwide in the USA and PR |
| Quantity | 69,239 vials |
| Recall 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. |
| Drug Classification | Class III |
| Drug Code Info | 20230531 |
| Recall Initiation Date | 20230508 |
| Report Date | 20230531 |
| Classification Date | 20230519 |
| Address | 50 Horseblock Rd Brookhaven, NY 11719-9509 United States |
| Recalling Firm | Amneal Pharmaceuticals of New York, LLC |
| Initial Notification | Letter |
| Similar To |