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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #s 19P0437 & 19P0438, Exp. 09/30/2021.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Jubilant Cadista Pharmaceuticals, Inc.
Reason for Recall:
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

Lot #s 19P0437 & 19P0438, Exp. 09/30/2021.

Distribution:

Distributed in: TN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1281-2020

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