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.
Reported: January 29, 2014 Initiated: November 14, 2013 #D-747-2014
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.
Reason for Recall
Failed Stability Specifications: this product is below specification for preservative content.
Details
- Recalling Firm
- Teva Pharmaceuticals USA, Inc.
- Units Affected
- 234,242 bottles
- Distribution
- Nationwide
- Location
- Sellersville, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA, Inc.. Units affected: 234,242 bottles.
Why was this product recalled? ▼
Failed Stability Specifications: this product is below specification for preservative content.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 29, 2014. Severity: Low. Recall number: D-747-2014.
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