FDA recall D-747-2014

Product

Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95.

Reason for recall

Failed Stability Specifications: this product is below specification for preservative content.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-11-14

Report date

2014-01-29

Termination date

2014-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-747-2014