FDA-Drug2019-01-02Class I
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.
Advanced Pharma Inc.
Hazard
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Sold states
Heath care facilities in NM, TX, and OH
Affected count
225 syringes
Manufactured in
9265 Kirby Dr, Houston, TX, United States
Products
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0347-2019Don't want to check this manually?
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