Moxifloxacin Ophthalmic Solution USP recall: Impurity Out of Spec
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
Why was Moxifloxacin Ophthalmic Solution USP recalled?
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
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 Numbers: H705562, H705563, EXP. 11/2019; H800616, EXP. 01/2020
- Product
- Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 43,860 3ml bottles
- Distribution
- Product was distributed by 5 wholesalers, 6 drug chains, 4 mail order pharmacies and 1 mail order pharmacy/supermarket who may have further distribute the product throughout the United States.
- Recall date
- February 20, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)