Class III
Terminated
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.
This recall has been terminated (originally issued June 3, 2020).
- Recall Initiated
- May 26, 2020
- Posted
- June 3, 2020
- Recall Number
- D-1281-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,313,333 tablets
- Firm Location
- Salisbury, MD, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Distribution
TN
Lot / Code Info
Lot #s 19P0437 & 19P0438, Exp. 09/30/2021.
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