FDA recall D-1356-2014

Pfizer Inc. · Class II · 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

Reason for recall

Defective Container: Tamper evident ring failures discovered on some bottles.

Distribution

Nationwide, Italy and Republic of South Korea

Key facts

Status: Terminated
Initiation date: 2014-01-29
Report date: 2014-06-11
Termination date: 2017-03-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1356-2014