Mislabeled Syringes Recalled

January 4, 2019

Advanced Pharma Inc. is recalling phenylephrine hydrochloride, 1 mg in sterile water for injection, QS 10-mL injectable solution, 1 mg/10 mL, 10-mL syringes (NDC 42852-802-61). According to the January 2, 2019, US Food and Drug Administration (FDA) Enforcement Report, the recalled syringes are incorrectly labeled as 10 mcg per mL rather than with the correct concentration of 100 mcg per mL.

Syringes included in the recall are from lot 11/01/18 8847 80261S, have a beyond-use date of March 31, 2019, and were distributed in New Mexico, Texas, and Ohio.

Advanced Pharma Inc. initiated the voluntary recall November 29, 2018. At the time of the enforcement report, the FDA had not yet issued a recall classification.

Phenylephrine hydrochloride injection is a prescription alpha-1 adrenergic receptor agonist used to treat hypotension resulting from vasodilation in anesthesia settings.

Jolynn Tumolo

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