Recalls / Class II
Class IID-0104-2021
Product
clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30
- Affected lot / code info
- Lot# 20P0141, exp. date 02/2022
Why it was recalled
Failed Tablet/Capsule Specification
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
- 4,416 bottles
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2020-11-06
- FDA classified
- 2020-11-24
- Posted by FDA
- 2020-12-02
- Terminated
- 2022-03-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0104-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.