Drug 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.
D-0576-2020
Product summary
- Event
- Event 84396
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,824 bottles
- Official record key
drug-enforcement:D-0576-2020
Official wording
Reason: Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Code information: Lot #: NT119005A, Exp 07/2021
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance