Recalls / Class III
Class IIID-1519-2016
Product
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.
- Brand name
- Lamotrigine
- Generic name
- Lamotrigine
- Active ingredient
- Lamotrigine
- Route
- Oral
- NDCs
- 29300-111, 29300-112, 29300-113, 29300-114
- FDA application
- ANDA090170
- Affected lot / code info
- Lot #: GLEH 16003, Exp 03/31/18
Why it was recalled
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Recalling firm
- Firm
- Unichem Pharmaceuticals Usa Inc
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 777 Terrace Ave, Suite 102, Hasbrouck Heights, New Jersey 07604-3102
Distribution
- Quantity
- 368 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-08-19
- FDA classified
- 2016-09-23
- Posted by FDA
- 2016-10-05
- Terminated
- 2017-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1519-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.