Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injecti
Summary
The FDA issued a Class III for Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscula by Amneal Pharmaceuticals of New York, LLC. Reason: Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packa.
Details
Source
Drug Recall
External ID
D-0756-2023
Action Date
2023-05-31
Status
Terminated
Category
drug
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/Code Info: Lot Numbers: AP220481, Exp 09/2024; AP220536A, Exp 10/2024
Quantity Affected: 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.
Distribution
Nationwide in the USA and PR
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-08
Company
Brookhaven, NY
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 216 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amneal Pharmaceuticals of New York, LLC has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Amneal Pharmaceuticals of New York, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amneal Pharmaceuticals of New York, LLC have FDA actions?
Amneal Pharmaceuticals of New York, LLC has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0756-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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