Lamotrigine Extended-Release Tablets recall: Failed Dissolution
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road…
Why was Lamotrigine Extended-Release Tablets recalled?
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: BFR5D002 EXP 11-2019
- Product
- Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road…
- Recalling firm
- Torrent Pharma Inc.
- Quantity
- 15,384 30-count bottles
- Distribution
- Nationwide USA
- Recall date
- September 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)