FDA recall D-0576-2020

Product

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.

Reason for recall

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

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2019-12-02

Report date

2019-12-18

Termination date

2021-10-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

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