fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.
Recall Number: D-0889-2018
Firm: Advanced Pharma Inc.
Classification: Class II
Status: Terminated
Report Date: 20180704
Initiation Date: 20180620
Termination Date: 20190403
Reason for Recall
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Product Description
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.