Recalls / Class III
Class IIID-1289-2020
Product
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.
- Brand name
- Lamotrigine
- Generic name
- Lamotrigine
- Active ingredient
- Lamotrigine
- Route
- Oral
- NDCs
- 42291-366, 42291-367, 42291-368, 42291-369
- FDA application
- ANDA079132
- Affected lot / code info
- Lot #: a) 25634, b) 25633; Exp. 09/30/2021
Why it was recalled
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Recalling firm
- Firm
- AVKARE Inc.
- Manufacturer
- AvKARE
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 4124 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-05-28
- FDA classified
- 2020-06-04
- Posted by FDA
- 2020-06-10
- Terminated
- 2021-10-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1289-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.