Class III
Terminated
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.
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- October 20, 2021
- Posted
- November 3, 2021
- Recall Number
- D-0091-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16,272 bottles
- Firm Location
- Baltimore, MD, United States
Reason for Recall
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
Lot # H002512, exp. date March 2022
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