The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1281-2020·Announced 2020-06-03

Lamotrigine Tablets Recalled for Presence of Foreign Silica Granules

Jubilant Cadista Pharmaceuticals is recalling Lamotrigine Tablets, 150 mg, due to the presence of foreign silica granules consistent with desiccant pack material.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk containers. The recall is due to the presence of a foreign substance visually consistent with silica granules found in desiccant packs used during product storage.

The affected product is identified by NDC 59746-247-97 and includes Lot #s 19P0437 and 19P0438 with an expiration date of 09/30/2021. The total quantity involved is 1,313,333 tablets. The product was manufactured by Jubilant Cadista Pharmaceuticals, Inc., in Salisbury, MD, and was intended for repackaging by AvKare Inc. in Pulaski, TN. Distribution was limited to Tennessee.

Consumers and healthcare providers should check their inventory for the specific lot numbers and NDC listed above. If found, the product should be returned to the supplier or disposed of according to local regulations. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product
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.
Manufacturer
Jubilant Cadista Pharmaceuticals, Inc.
Category
Drug — Anticonvulsant
Hazard
Affected units
1,313,333

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed in 1 state:

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