FDA recall D-1281-2020

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.

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

Key facts

Status

Terminated

Initiation date

2020-05-26

Report date

2020-06-03

Termination date

2022-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1281-2020