Why it was recalled
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Product description
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30
Lot numbers, UPCs & expiration codes
Lot: BFR5D002 EXP 11-2019
Where it was sold
Nationwide USA
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-1204-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 11, 2018
- FDA report date
- Sep 26, 2018
- Quantity
- 15,384 30-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Torrent Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-1204-2018, exactly as published.
Show all FDA fields
- City
- Kalamazoo
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 80985
- Address
- 1803 Whites Rd Ste 1
- Code information
- Lot: BFR5D002 EXP 11-2019
- Postal code
- 49008-2883
- Report date
- Sep 26, 2018
- Product type
- Drugs
- Recall number
- D-1204-2018
- Classification
- Class II
- Recalling firm
- Torrent Pharma Inc.
- Product quantity
- 15,384 30-count bottles
- Termination date
- Sep 4, 2020
- Reason for recall
- Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Sep 11, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 20, 2018