D-0576-2020 Class II Terminated
FDA drug recall D-0576-2020 was initiated by Jubilant Cadista Pharmaceuticals, Inc. on December 2, 2019 and is designated Class II. Reason for recall: Presence of Foreign Substance: Presence of a foreign object in a single tablet. The recall status is terminated (terminated October 14, 2021). Affected quantity: 1,824 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 18, 2019
- Initiation Date
- December 2, 2019
- Termination Date
- October 14, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,824 bottles
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.
Reason for Recall
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: NT119005A, Exp 07/2021