Drug Enforcement D-0756-2023

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.

Status

Terminated

Classification

Class III

Report Date

May 31, 2023

Termination Date

March 21, 2024

Product Information

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.
Product quantity
69,239 vials
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA and PR

Location & Firm

Recalling firm
Amneal Pharmaceuticals of New York, LLC
Address
50 Horseblock Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0756-2023
Event ID
92249
Recall initiation date
May 8, 2023
Center classification date
May 19, 2023
Code info
Lot Numbers: AP220481, Exp 09/2024; AP220536A, Exp 10/2024
More code info
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