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.
Reported: December 1, 2021 Initiated: October 25, 2021 #D-0255-2022
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.
Reason for Recall
Discoloration
Details
- Recalling Firm
- UNICHEM PHARMACEUTICALS USA INC
- Units Affected
- 1284 bottles
- Distribution
- Nationwide within the United States
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by UNICHEM PHARMACEUTICALS USA INC. Units affected: 1284 bottles.
Why was this product recalled? ▼
Discoloration
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 1, 2021. Severity: Low. Recall number: D-0255-2022.
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