FDAFDA · Food and drugs·Recall number D-1281-2020
Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97.
Published June 3, 2020 · Recall initiated: May 26, 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 visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Distributor
- TN
- Lot
- Lot #s 19P0437 & 19P0438, Exp. 09/30/2021.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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