Moxifloxacin Ophthalmic Solution USP recall: Impurity Out of Spec
Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United…
Why was Moxifloxacin Ophthalmic Solution USP recalled?
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three 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 #: H800393, Exp. 01/2020
- Product
- Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 13,896 bottles
- Distribution
- Product was distributed throughout the United States
- Recall date
- August 8, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)