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.
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.
Lot numbers, UPCs & expiration codes
Lot #s 19P0437 & 19P0438, Exp. 09/30/2021.
Where it was sold
TN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1281-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 26, 2020
- FDA report date
- Jun 3, 2020
- Quantity
- 1,313,333 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1281-2020, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 85752
- Address
- 207 Kiley Dr
- Code information
- Lot #s 19P0437 & 19P0438, Exp. 09/30/2021.
- Postal code
- 21801-2249
- Report date
- Jun 3, 2020
- Product type
- Drugs
- Recall number
- D-1281-2020
- Classification
- Class III
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 1,313,333 tablets
- Termination date
- Nov 15, 2022
- Reason for recall
- Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- TN
- Recall initiation date
- May 26, 2020
- Initial firm notification
- Letter
- Center classification date
- May 29, 2020