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Class III · Lower riskRecall completed

Methylprednisolone Acetate Injectable Suspension

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot Numbers: AP220481, Exp 09/2024; AP220536A, Exp 10/2024
Where it was soldNationwide in the USA and PR
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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 [redacted-phone]-1; Correct NDC Number [redacted-phone]-1.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Pharamceuticals LLC, Bridgewater, NJ 08807 foreign manufacturer
Distributed by / forAmneal Pharmaceuticals of New York, LLC
NDC70121-1574-01
Show the full FDA record
Full product labelMethylprednisolone 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.
Recalling firmAmneal Pharmaceuticals of New York, LLC
DistributionNationwide in the USA and PR
Quantity69,239 vials
Recall initiated2023-05-08
Report date2023-05-31
Recall completed2024-03-21
Recall numberD-0756-2023
ClassificationClass III
FDA statusTerminated
Origin on fileBrookhaven NY United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.