Why it was recalled
Discoloration
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 numbers, UPCs & expiration codes
Lot #: ZTPM20044, Exp. Date 09/30/2022
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0255-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 25, 2021
- FDA report date
- Dec 1, 2021
- Quantity
- 1284 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- UNICHEM PHARMACEUTICALS USA INC
Original FDA data
Every field from FDA enforcement report D-0255-2022, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88891
- Address
- 1 Tower Center Blvd Ste 2200
- Code information
- Lot #: ZTPM20044, Exp. Date 09/30/2022
- Postal code
- 08816-1145
- Report date
- Dec 1, 2021
- Product type
- Drugs
- Recall number
- D-0255-2022
- Classification
- Class III
- Recalling firm
- UNICHEM PHARMACEUTICALS USA INC
- Product quantity
- 1284 bottles
- Termination date
- Oct 12, 2022
- Reason for recall
- Discoloration
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 25, 2021
- Center classification date
- Nov 19, 2021