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
Reported: February 8, 2017 Initiated: December 28, 2016 #D-0450-2017
Product Description
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
Reason for Recall
Failed Dissolution Specifications; 18 month stability time point
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- a) 42,984 and b) 7,764 bottles
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: a) 42,984 and b) 7,764 bottles.
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-0450-2017.
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