Reported Sep 18, 2019 · Terminated
Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV…
Mylan Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan Pharmaceuticals Inc. · 781 Chestnut Ridge Rd · Morgantown, WV · 26505-2730
Is this the product you have?
- Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd
- forMylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India
- NDC0378-5431-35
- Lot codes and dates
Lot GABH0003EXP 7/2020
- Amount recalled
- 13,157 5 mL bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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