FDAFDA · Food and drugs·Recall number D-1848-2019
Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35
Published September 18, 2019 · Recall initiated: September 6, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot GABH0003, EXP 7/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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