Impax Recalls Lamotrigine Tablets Due to Labeling Mixup
Impax Laboratories is recalling 3,074 boxes of Lamotrigine Orally Disintegrating Tablets because some 200 mg boxes contained 100 mg tablets.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric, as it poses a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Impax Laboratories, Inc. is recalling 3,074 boxes of Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg. The product is distributed nationwide and was manufactured by Watson Pharma Private Ltd. in India. The specific lot number is 502240, with an expiry date of 11/2017.
The recall was initiated due to a labeling mixup. Some boxes labeled to contain 200 mg blister packs actually contained 100 mg blister packs. This discrepancy could result in patients receiving a lower dose than prescribed.
Consumers and healthcare providers should check their inventory for this specific lot number and stop using the product if it matches the description. They should contact their pharmacist or Impax Laboratories for further instructions on how to return or dispose of the affected medication.
The recalled product
- Product
- Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
- Manufacturer
- Impax Laboratories, Inc.
- Category
- Drug — Anticonvulsant
- Hazard
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 Number 502240
- expiry date 11/2017
Distribution
Distributed nationwide across the United States.
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