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Recall Observatory FDA recall evidence

Drug product

Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India

D-0450-2017

December 28, 2016

Class II

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 76122
Status
Terminated
Classification
Class II
Quantity
a) 42,984 and b) 7,764 bottles
Official record key
drug-enforcement:D-0450-2017

Official wording

Reason: Failed Dissolution Specifications; 18 month stability time point

Code information: a) 30 count C500224, exp 12/2016, C500846, exp 01/2017 b) 100 count C500224, exp 12/2016, exp 12/2016, C501608, exp 02/2017 and C503655, exp 04/2017

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications