Recalls / Class III
Class IIID-1546-2022
Product
ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01
- Brand name
- Clomipramine Hydrochloride
- Generic name
- Clomipramine Hydrochloride
- Active ingredient
- Clomipramine Hydrochloride
- Route
- Oral
- NDCs
- 69315-165, 69315-167, 69315-166
- FDA application
- ANDA211364
- Affected lot / code info
- Lot#: B14221, Exp. Date 02/2023
Why it was recalled
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Recalling firm
- Firm
- Leading Pharma, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Oak Rd, N/A, Fairfield, New Jersey 07004-2903
Distribution
- Quantity
- 960 bottles (100 capsules)
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-08-23
- FDA classified
- 2022-09-28
- Posted by FDA
- 2022-10-05
- Terminated
- 2023-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1546-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.