Why it was recalled
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Product description
Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.
Lot numbers, UPCs & expiration codes
Lot #: GLEH 16003, Exp 03/31/18
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1519-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 19, 2016
- FDA report date
- Oct 5, 2016
- Quantity
- 368 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Unichem Pharmaceuticals Usa Inc
Original FDA data
Every field from FDA enforcement report D-1519-2016, exactly as published.
Show all FDA fields
- City
- Hasbrouck Heights
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75205
- Address
- 777 Terrace Ave
- Address (line 2)
- Suite 102
- Code information
- Lot #: GLEH 16003, Exp 03/31/18
- Postal code
- 07604-3102
- Report date
- Oct 5, 2016
- Product type
- Drugs
- Recall number
- D-1519-2016
- Classification
- Class III
- Recalling firm
- Unichem Pharmaceuticals Usa Inc
- Product quantity
- 368 bottles
- Termination date
- Feb 7, 2017
- Reason for recall
- Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 19, 2016
- Initial firm notification
- Letter
- Center classification date
- Sep 23, 2016