Amneal Pharmaceuticals of New York, LLC recalls Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Inject…

Recall date

May 8, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0756-2023

FDA classification

Class III

Brand / firm

Amneal Pharmaceuticals of New York, LLC

Sold / distributed

Nationwide in the USA and PR

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.