FDA-Drug2018-07-04Class II

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.

Advanced Pharma Inc.
Hazard

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

Sold states
Distributed to one medical center in Fort Worth, TX.
Affected count
100 syringes
Manufactured in
9265 Kirby Dr, Houston, TX, United States
Products
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.

Official notice

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

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