clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Reported: July 30, 2025 Initiated: June 27, 2025 #D-0537-2025
Product Description
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Reason for Recall
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 2,724 bottles
- Distribution
- Nationwide.
- Location
- Naples, FL
Frequently Asked Questions
What product was recalled? ▼
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 2,724 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 30, 2025. Severity: Moderate. Recall number: D-0537-2025.
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