D-1848-2019 Class III Terminated
FDA drug recall D-1848-2019 was initiated by Mylan Pharmaceuticals Inc. on Sep 6, 2019 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications:OOS for unknown impurity. The recall status is terminated (terminated Jul 16, 2020). Affected quantity: 13,157 5 mL bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 18, 2019
- Initiation Date
- Sep 6, 2019
- Termination Date
- Jul 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,157 5 mL bottles
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.
Distribution pattern
Nationwide in the USA
Code information
Lot GABH0003, EXP 7/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1848-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026