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Recall Observatory FDA recall evidence

Drug product

Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01

D-1518-2019

July 17, 2019

Class III

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 83350
Status
Terminated
Classification
Class III
Quantity
33,939 tubes
Official record key
drug-enforcement:D-1518-2019

Official wording

Reason: Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.

Code information: Lot #: K800245, Exp. Dec 2019; K900036 Exp. Sep 20; K900153, Exp. 09/2020

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-of-specification