Drug recall D-1204-2018
Product
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
Reason for recall
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Lots and codes
Lot: BFR5D002 EXP 11-2019
Recall details
- Recalling firm
- Torrent Pharma Inc., Kalamazoo, MI
- Quantity
- 15,384 30-count bottles
- Distribution
- Nationwide USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 11, 2018
- Terminated
- September 4, 2020
Related products
- Lamotrigine – drug information
- NDC 13668-339 Lamotrigine · Lamotrigine 25 mg/1 · Torrent Pharmaceuticals Limited
- NDC 13668-341 Lamotrigine · Lamotrigine 100 mg/1 · Torrent Pharmaceuticals Limited
- NDC 13668-340 Lamotrigine · Lamotrigine 50 mg/1 · Torrent Pharmaceuticals Limited