FDA-Drug2023-08-09Class II
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
Hazard
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Sold states
Nationwide in the USA
Affected count
499,304 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, 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-0965-2023Don't want to check this manually?
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