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
Reported: September 18, 2019 Initiated: September 6, 2019 #D-1848-2019
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 13,157 5 mL bottles
- Distribution
- Nationwide in the USA
- Location
- Morgantown, WV
Frequently Asked Questions
What product 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. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 13,157 5 mL bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 18, 2019. Severity: Low. Recall number: D-1848-2019.
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