Recalls / Class III
Class IIID-0756-2023
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.
- Affected lot / code info
- Lot Numbers: AP220481, Exp 09/2024; AP220536A, Exp 10/2024
Why it was recalled
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.
Recalling firm
- Firm
- Amneal Pharmaceuticals of New York, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, N/A, Brookhaven, New York 11719-9509
Distribution
- Quantity
- 69,239 vials
- Distribution pattern
- Nationwide in the USA and PR
Timeline
- Recall initiated
- 2023-05-08
- FDA classified
- 2023-05-19
- Posted by FDA
- 2023-05-31
- Terminated
- 2024-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0756-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.