Recalls / Class II
Class IID-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.
- Affected lot / code info
- Lot #: NT119005A, Exp 07/2021
Why it was recalled
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, N/A, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 1,824 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2019-12-02
- FDA classified
- 2019-12-06
- Posted by FDA
- 2019-12-18
- Terminated
- 2021-10-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0576-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.