Recalls / Class I
Class ID-0215-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lot Number 502240, expiry date 11/2017
Why it was recalled
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Recalling firm
- Firm
- Impax Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 31153 San Antonio Street, N/A, Hayward, California 94544
Distribution
- Quantity
- 3,074 boxes (30 count boxes)
- Distribution pattern
- Distributed Nationwide
Timeline
- Recall initiated
- 2016-08-19
- FDA classified
- 2016-12-22
- Posted by FDA
- 2016-12-28
- Terminated
- 2017-06-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0215-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.