FDA Drug Class II — Moderate

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.

Hazard

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

Products

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 2
Brand
Jubilant Cadista Pharmaceuticals, Inc.
UPC
Lot #: NT119005A, Exp 07/2021

Units Affected

1,824 bottles