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.