FDA Drug Moderate Class II Terminated

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

Reported: February 8, 2017 Initiated: December 28, 2016 #D-0451-2017

Product Description

Reason for Recall

Failed Dissolution Specifications; 18 month stability time point

Details

Recalling Firm: Dr. Reddy's Laboratories, Inc.
Units Affected: 59,440 blister cards
Distribution: Nationwide
Location: Princeton, NJ

Frequently Asked Questions

What product was recalled? ▼

Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 59,440 blister cards.

Why was this product recalled? ▼

Failed Dissolution Specifications; 18 month stability time point

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on February 8, 2017. Severity: Moderate. Recall number: D-0451-2017.

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