FDA-Drug2019-12-18Class II

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.

Jubilant Cadista Pharmaceuticals, Inc.
Hazard

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

Sold states
Nationwide in the USA.
Affected count
1,824 bottles
Manufactured in
207 Kiley Dr, N/A, Salisbury, MD, United States
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 21801, USA; NDC 59746-699-01.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0576-2020

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