Recalls / Class II
Class IID-0449-2017
Product
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
- Brand name
- Fluconazole
- Generic name
- Fluconazole
- Active ingredient
- Fluconazole
- Route
- Oral
- NDCs
- 55111-143, 55111-144, 55111-145, 55111-146
- FDA application
- ANDA076658
- Affected lot / code info
- a) 30 count C500221, exp 12/2016, C502342, exp 03/2017 b) 100 count C500221, exp 12/2016, C502342, exp 03/2017
Why it was recalled
Failed Dissolution Specifications; 18 month stability time point
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- a) 2472 bottles, b) 780 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-12-28
- FDA classified
- 2017-01-30
- Posted by FDA
- 2017-02-08
- Terminated
- 2017-10-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0449-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.