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.
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.
Lot numbers, UPCs & expiration codes
Lot Numbers: AP220481, Exp 09/2024; AP220536A, Exp 10/2024
Where it was sold
Nationwide in the USA and PR
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0756-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 8, 2023
- FDA report date
- May 31, 2023
- Quantity
- 69,239 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
Original FDA data
Every field from FDA enforcement report D-0756-2023, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 92249
- Address
- 50 Horseblock Rd
- Code information
- Lot Numbers: AP220481, Exp 09/2024; AP220536A, Exp 10/2024
- Postal code
- 11719-9509
- Report date
- May 31, 2023
- Product type
- Drugs
- Recall number
- D-0756-2023
- Classification
- Class III
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Product quantity
- 69,239 vials
- Termination date
- Mar 21, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA and PR
- Recall initiation date
- May 8, 2023
- Initial firm notification
- Letter
- Center classification date
- May 19, 2023