Class II
Terminated
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
- Company
- Torrent Pharma Inc.
- Recall Initiated
- September 11, 2018
- Posted
- September 26, 2018
- Recall Number
- D-1204-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 15,384 30-count bottles
- Firm Location
- Kalamazoo, MI, United States
Reason for Recall
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Distribution
Nationwide USA
Lot / Code Info
Lot: BFR5D002 EXP 11-2019
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