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Recall Observatory FDA recall evidence

Drug product

Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India

D-0452-2017

December 28, 2016

Class II

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 76122
Status
Terminated
Classification
Class II
Quantity
a) 38,832 and b) 5,064 bottles
Official record key
drug-enforcement:D-0452-2017

Official wording

Reason: Failed Dissolution Specifications; 18 month stability time point

Code information: a) 30 count C500228, exp 12/2016, C500848 and C500850, exp 01/2017 C503651 and C503653, exp 04/2017, b) 100 count C500226, exp 12/2016, C500848, C500850, exp 01/2017, C503649 and C503653, exp 04/2017

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications