D-0756-2023 Class III Terminated
FDA drug recall D-0756-2023 was initiated by Amneal Pharmaceuticals of New York, LLC on May 8, 2023 and is designated Class III. 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; Cor… The recall status is terminated (terminated March 21, 2024). Affected quantity: 69,239 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2023
- Initiation Date
- May 8, 2023
- Termination Date
- March 21, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69,239 vials
Product 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.
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 Pattern
Nationwide in the USA and PR
Code Information
Lot Numbers: AP220481, Exp 09/2024; AP220536A, Exp 10/2024