Drug recall D-0451-2017

Class II Terminated reported Feb 8, 2017

Product

Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12

Reason for recall

Failed Dissolution Specifications; 18 month stability time point

Lots and codes

C500222, C500515, and C500517, exp 12/2016, C502343, exp 03/2017

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
59,440 blister cards
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
December 28, 2016
Terminated
October 19, 2017

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