PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 6, 2023 Initiated: August 17, 2023 #D-1124-2023

Product Description

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

Reason for Recall

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

Details

Units Affected
4100 syringes
Distribution
Nationwide in the USA
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
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. Recalled by Central Admixture Pharmacy Services, Inc.. Units affected: 4100 syringes.
Why was this product recalled?
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Which agency issued this recall?
This recall was issued by the FDA Drug on September 6, 2023. Severity: Moderate. Recall number: D-1124-2023.