Drug product
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
D-0537-2025
Product summary
- Event
- Event 97159
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,724 bottles
- Official record key
drug-enforcement:D-0537-2025
Official wording
Reason: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Code information: Lot # M300464, exp. date June, 2025
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
out of specification