FDA recall D-0889-2018

Product

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.

Reason for recall

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

Distribution

Distributed to one medical center in Fort Worth, TX.

Key facts

Status

Terminated

Initiation date

2018-06-20

Report date

2018-07-04

Termination date

2019-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0889-2018