D-1204-2018 Class II Terminated
FDA drug recall D-1204-2018 was initiated by Torrent Pharma Inc. on Sep 11, 2018 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing. The recall status is terminated (terminated Sep 4, 2020). Affected quantity: 15,384 30-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 26, 2018
- Initiation Date
- Sep 11, 2018
- Termination Date
- Sep 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,384 30-count bottles
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
Reason for Recall
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Distribution Pattern
Nationwide USA
Code Information
Lot: BFR5D002 EXP 11-2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1204-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026