Advanced Pharma Inc. recalls Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (
Recalled January 2, 2019 · FDA recall D-0347-2019 · Advanced Pharma
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". · FDA Class I
Units
225 syringes
Sold at
Heath care facilities in NM, TX, and OH
Description
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".
Product
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.
Manufacturer(s)
Advanced Pharma Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →