FDAFDA · Food and drugs·Recall number D-1289-2020
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.
Published June 10, 2020 · Recall initiated: May 28, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LAMOTRIGINE
- Manufacturer
- AVKARE Inc.
- Distributor
- Nationwide in the U.S.
- UPC
- 0342291368606
- Lot
- Lot #: a) 25634, b) 25633; Exp. 09/30/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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