Reported Oct 5, 2016 · Terminated
Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by
Unichem Pharmaceuticals USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Unichem Pharmaceuticals Usa Inc · 777 Terrace Ave · Hasbrouck Heights, NJ · 07604-3102
Is this the product you have?
Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India |
| 2 | Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662 |
| 3 | NDC 29300-113-05. |
- Lot codes and dates
Lot #: GLEH 16003Exp 03/31/18
- Amount recalled
- 368 bottles
Where it was sold
- Nationwide
Why it was recalled
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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