Drug 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
D-1356-2014
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 67532
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,155 bottles
- Official record key
drug-enforcement:D-1356-2014
Official wording
Reason: Defective Container: Tamper evident ring failures discovered on some bottles.
Code information: Lot # A358502; Exp 01/15
Distribution pattern: Nationwide, Italy and Republic of South Korea
Derived failure modes
-
Unknown
Defective Container: Tamper evident ring failures discovered on some bottles.