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Hypotension Injection Recalled


December 21, 2016

Cantrell Drug Company has recalled more than 30,000 syringes of Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride due to a lack of assurance of sterility.

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Phenylephrine Hydrochloride Injection is an alpha-1 adrenergic receptor agonist that is used to increase blood pressure in adults with hypotension, which may occur as a result of septic shock or anesthesia.

The recall was given a class II designation, meaning that use or exposure to phenylephrine hydrochloride injection could cause temporary or medically reversible adverse health consequences, with little chance for serious side effects.—Sean McGuire 

Reference

Enforcement Report. US Food and Drug Administration Website. http://www.accessdata.fda.gov/scripts/ires/index.cfm. Published December 21, 2016. Accessed December 21, 2016. 

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