clomiPRAMINE Hydrochloride Capsules USP 25 mg recall: Impurity Out of Spec
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Why was clomiPRAMINE Hydrochloride Capsules USP 25 mg 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # M300464, exp. date June, 2025
- Product
- clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 2,724 bottles
- Distribution
- Nationwide.
- Recall date
- July 30, 2025
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)