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.
Recall Number: D-747-2014
Firm: Teva Pharmaceuticals USA, Inc.
Classification: Class III
Status: Terminated
Report Date: 20140129
Initiation Date: 20131114
Termination Date: 20140827
Reason for Recall
Failed Stability Specifications: this product is below specification for preservative content.
Product Description
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.