Drug recall D-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.
Reason for recall
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Lots and codes
Lot #: GLEH 16003, Exp 03/31/18
Recall details
- Recalling firm
- Unichem Pharmaceuticals Usa Inc, Hasbrouck Heights, NJ
- Quantity
- 368 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 19, 2016
- Terminated
- February 7, 2017
Related products
- Lamotrigine – drug information
- NDC 29300-114 Lamotrigine · Lamotrigine 200 mg/1 · Unichem Pharmaceuticals (USA), Inc.
- NDC 29300-113 Lamotrigine · Lamotrigine 150 mg/1 · Unichem Pharmaceuticals (USA), Inc.
- NDC 29300-112 Lamotrigine · Lamotrigine 100 mg/1 · Unichem Pharmaceuticals (USA), Inc.
- NDC 29300-111 Lamotrigine · Lamotrigine 25 mg/1 · Unichem Pharmaceuticals (USA), Inc.