Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01.

Recall Number: D-0576-2020

Firm: Jubilant Cadista Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20191218

Initiation Date: 20191202

Termination Date: 20211014

Reason for Recall

Presence of Foreign Substance: Presence of a foreign object in a single tablet.

Product Description

Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01.