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
Reported: September 26, 2018 Initiated: September 11, 2018 #D-1204-2018
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.
Details
- Recalling Firm
- Torrent Pharma Inc.
- Units Affected
- 15,384 30-count bottles
- Distribution
- Nationwide USA
- Location
- Kalamazoo, MI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Torrent Pharma Inc.. Units affected: 15,384 30-count bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 26, 2018. Severity: Moderate. Recall number: D-1204-2018.
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