Mylan Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV…
- Recall date
- September 6, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1848-2019
- FDA classification
- Class III
- Brand / firm
- Mylan Pharmaceuticals Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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