Lupin Pharmaceuticals Inc. recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 7
Recalled March 6, 2019 · FDA recall D-0517-2019 · Lupin Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities. · FDA Class III
Units
674,628 bottles
Sold at
Nationwide in the USA and Puerto Rico.
Description
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Product
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →