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.