Recalls / Class III
Class IIID-0091-2022
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.
- Affected lot / code info
- Lot # H002512, exp. date March 2022
Why it was recalled
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 16,272 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2021-10-20
- FDA classified
- 2021-11-02
- Posted by FDA
- 2021-11-03
- Terminated
- 2022-08-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0091-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.