D-0091-2022 Class III Terminated
FDA drug recall D-0091-2022 was initiated by Lupin Pharmaceuticals Inc. on October 20, 2021 and is designated Class III. 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. The recall status is terminated (terminated August 23, 2022). Affected quantity: 16,272 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 3, 2021
- Initiation Date
- October 20, 2021
- Termination Date
- August 23, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,272 bottles
Product Description
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.
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 Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot # H002512, exp. date March 2022