Teva Pharmaceuticals USA, Inc. recalls Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceutica
Recalled January 29, 2014 · FDA recall D-747-2014 · Teva Pharmaceuticals USA
Hazard
Failed Stability Specifications: this product is below specification for preservative content. · FDA Class III
Units
234,242 bottles
Sold at
Nationwide
Description
Failed Stability Specifications: this product is below specification for preservative content.
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.
Manufacturer(s)
Teva Pharmaceuticals USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →