Recalls / Class III
Class IIID-1848-2019
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: 0378-5431-35
- Affected lot / code info
- Lot GABH0003, EXP 7/2020
Why it was recalled
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 13,157 5 mL bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-09-06
- FDA classified
- 2019-09-09
- Posted by FDA
- 2019-09-18
- Terminated
- 2020-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1848-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.