Gatifloxacin Ophthalmic Solution 0.5% recall: Impurity Out of Spec
Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC…
Why was Gatifloxacin Ophthalmic Solution 0.5% recalled?
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
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 GABH0003, EXP 7/2020
- Product
- Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC…
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 13,157 5 mL bottles
- Distribution
- Nationwide in the USA
- Recall date
- September 18, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)