Recalls / Class III
Class IIID-0784-2021
Product
Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90
- Affected lot / code info
- Lot # DN120006A, exp. date 12/2021
Why it was recalled
Subpotent
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
- 14,544 bottles
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2021-08-20
- FDA classified
- 2021-08-31
- Posted by FDA
- 2021-09-08
- Terminated
- 2022-04-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0784-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.