Unichem Recalls Lamotrigine Tablets With Incorrect Imprint
Unichem Pharmaceuticals is recalling 368 bottles of Lamotrigine 150 mg tablets because they have the wrong imprint. The FDA classifies this as Class III.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, and the hazard is limited to an incorrect imprint (documentation/packaging issue) with no reported health risks.
Plain-English summary
Unichem Pharmaceuticals (USA), Inc. is recalling 368 bottles of Lamotrigine Tablets, USP, 150 mg. The product is identified by NDC 29300-113-05, Lot # GLEH 16003, and an expiration date of 03/31/18. The tablets were manufactured by Unichem Laboratories LTD. in India and marketed by Unichem Pharmaceuticals (USA), Inc. in Rochelle Park, NJ.
The recall was initiated because the tablets have an incorrect imprint debossed on them. This is a labeling and identification error rather than a chemical or potency defect. The FDA has classified this recall as Class III, which indicates that the use of or exposure to the product is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for bottles matching the specific NDC, lot number, and expiration date listed above. If found, the product should be returned to the pharmacy or distributor for replacement or refund.
The recalled product
- Product
- LAMOTRIGINE (LAMOTRIGINE)
- Brand
- LAMOTRIGINE
- Manufacturer
- Unichem Pharmaceuticals Usa Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 368
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: GLEH 16003
- Exp 03/31/18
UPCs (3)
- 0329300113167
- 0329300111019
- 0329300114164
Distribution
Distributed nationwide across the United States.
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