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-0326-2022
Product summary
- Event
- Event 89268
- Status
- Terminated
- Classification
- Class III
- Quantity
- 50,832 bottles
- Official record key
drug-enforcement:D-0326-2022
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 #: H003037, exp. date May 2022; H100132, exp. date June 2022; H100847, exp. date October 2022
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out-of-specification