Recalls / Class II
Class IID-0689-2017
Product
Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61
- Brand name
- Fluconazole
- Generic name
- Fluconazole
- Active ingredient
- Fluconazole
- Route
- Oral
- NDCs
- 0904-6500, 0904-6501
- FDA application
- ANDA076658
- Affected lot / code info
- Lot #:T-00519, Exp. 01-17
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- The Harvard Drug Group
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17177 N Laurel Park Dr Ste 233, Livonia, Michigan 48152-3951
Distribution
- Quantity
- 914 cartons
- Distribution pattern
- Nationwide within the US
Timeline
- Recall initiated
- 2017-01-05
- FDA classified
- 2017-04-28
- Posted by FDA
- 2017-05-10
- Terminated
- 2017-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0689-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.