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Recall Observatory FDA recall evidence

Drug product

Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.

D-0635-2020

December 13, 2019

Class III

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 84495
Status
Terminated
Classification
Class III
Quantity
2,130 bottles
Official record key
drug-enforcement:D-0635-2020

Official wording

Reason: Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.

Code information: Lot# H801686, Exp. 12/31/2019.

Distribution pattern: Nationwide in the U.S.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-of-specification