D-0326-2022 Class III Terminated
FDA drug recall D-0326-2022 was initiated by Lupin Pharmaceuticals Inc. on December 22, 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 September 12, 2022). Affected quantity: 50,832 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 12, 2022
- Initiation Date
- December 22, 2021
- Termination Date
- September 12, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50,832 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 #: H003037, exp. date May 2022; H100132, exp. date June 2022; H100847, exp. date October 2022