Topiramate 50 mg tablets recalled due to discoloration
Unichem Pharmaceuticals USA Inc is recalling Topiramate 50 mg tablets nationwide due to discoloration. The affected lot is ZTPM20044, expiring 09/30/2022.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall for discoloration, a cosmetic defect with no reported illnesses or injuries. Per the severity rubric, cosmetic defects are rated as Low (score 1).
Plain-English summary
Unichem Pharmaceuticals USA Inc is voluntarily recalling Topiramate Tablets, USP 50 mg in 500-count bottles nationwide within the United States. The recall affects 1,284 bottles from Lot #ZTPM20044 with an expiration date of 09/30/2022. The reason for the recall is discoloration of the tablets.
The affected product is manufactured by Unichem Laboratories LTD in Ghaziabad, India, and manufactured for Unichem Pharmaceuticals (USA), Inc. in East Brunswick, New Jersey. The product is identified by NDC 29300-116-05. Topiramate is a prescription medication used to treat certain seizure disorders and other conditions.
Consumers with affected bottles should contact their pharmacist or healthcare provider before discontinuing use of this medication. The recall was initiated by the firm on October 25, 2021, and terminated on October 12, 2022.
The recalled product
- Product
- TOPIRAMATE (TOPIRAMATE)
- Brand
- TOPIRAMATE
- Manufacturer
- UNICHEM PHARMACEUTICALS USA INC
- Hazard
- Affected units
- 1,284
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: ZTPM20044
- Exp. Date 09/30/2022
UPCs (1)
- 0329300118162
Distribution
Distributed nationwide across the United States.
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