FDA-Drug2023-09-06Class II

PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1

Central Admixture Pharmacy Services, Inc.
Hazard

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Sold states
Nationwide in the USA
Affected count
4100 syringes
Manufactured in
2200 S 43rd Ave, N/A, Phoenix, AZ, United States
Products
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1124-2023

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