Jubilant Cadista Pharmaceuticals, Inc. recalls Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc.,…
- Recall date
- May 26, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1281-2020
- FDA classification
- Class III
- Brand / firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Sold / distributed
- TN
Why it was recalled
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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