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Recall Observatory FDA recall evidence

Drug 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.

D-0091-2022

October 20, 2021

Class III

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 88885
Status
Terminated
Classification
Class III
Quantity
16,272 bottles
Official record key
drug-enforcement:D-0091-2022

Official wording

Reason: Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.

Code information: Lot # H002512, exp. date March 2022

Distribution pattern: Nationwide in the USA and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-of-specification