Advanced Pharma Inc. recalls fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharm…

Recall date

June 20, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0889-2018

FDA classification

Class II

Brand / firm

Advanced Pharma Inc.

Sold / distributed

Distributed to one medical center in Fort Worth, TX.

Why it was recalled

Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.