clomiPRAMINE hydrochloride Capsules USP recall: Impurity Out of Spec
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United…
Why was clomiPRAMINE hydrochloride Capsules USP recalled?
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
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 #: M300442, Exp Date: 6/30/2025
- Product
- clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 2724 bottles
- Distribution
- USA nationwide
- Recall date
- April 30, 2025
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)