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.
Reported: June 3, 2020 Initiated: May 26, 2020 #D-1281-2020
Product Description
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.
Reason for Recall
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Units Affected
- 1,313,333 tablets
- Distribution
- TN
- Location
- Salisbury, MD
Frequently Asked Questions
What product 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.. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: 1,313,333 tablets.
Why was this product recalled? ▼
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 3, 2020. Severity: Low. Recall number: D-1281-2020.
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