Drug product
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
D-0091-2022
Product summary
- Event
- Event 88885
- Status
- Terminated
- Classification
- Class III
- Quantity
- 16,272 bottles
- Official record key
drug-enforcement:D-0091-2022
Official wording
Reason: Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Code information: Lot # H002512, exp. date March 2022
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out-of-specification