Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut
Summary
The FDA issued a Class III for Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unic by UNICHEM PHARMACEUTICALS USA INC. Reason: Discoloration.
Details
Source
Drug Recall
External ID
D-0255-2022
Action Date
2021-12-01
Status
Terminated
Category
drug
Product Description
Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.
Lot/Code Info: Lot #: ZTPM20044, Exp. Date 09/30/2022
Quantity Affected: 1284 bottles
Reason for Recall
Discoloration
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-25
Company
East Brunswick, NJ
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 34 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
UNICHEM PHARMACEUTICALS USA INC has 6 FDA actions in our database, including 6 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 (UNICHEM PHARMACEUTICALS USA INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does UNICHEM PHARMACEUTICALS USA INC have FDA actions?
UNICHEM PHARMACEUTICALS USA INC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0255-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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