Recalls / Class II
Class IID-1356-2014
Product
GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1
- Brand name
- Fluconazole
- Generic name
- Fluconazole
- Active ingredient
- Fluconazole
- Route
- Oral
- NDCs
- 59762-5029, 59762-5015, 59762-5016, 59762-5017, 59762-5018, 59762-5030
- FDA application
- NDA020090
- Affected lot / code info
- Lot # A358502; Exp 01/15
Why it was recalled
Defective Container: Tamper evident ring failures discovered on some bottles.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Quantity
- 4,155 bottles
- Distribution pattern
- Nationwide, Italy and Republic of South Korea
Timeline
- Recall initiated
- 2014-01-29
- FDA classified
- 2014-05-30
- Posted by FDA
- 2014-06-11
- Terminated
- 2017-03-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1356-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.