FDAClass IIIMay 31, 2023

Methylprednisolone Acetate Injectable Suspension recall: Labeling Error

Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous…

Why was Methylprednisolone Acetate Injectable Suspension 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: AP220481, Exp 09/2024; AP220536A, Exp 10/2024

Product
Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous…
Recalling firm
Amneal Pharmaceuticals of New York, LLC
Quantity
69,239 vials
Distribution
Nationwide in the USA and PR
Recall date
May 31, 2023
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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