PlainRecalls
FDA Drug Moderate Class II Terminated

PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1

Reported: August 9, 2023 Initiated: July 17, 2023 #D-1078-2023

Product Description

PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1

Reason for Recall

Lack of assurance of sterility: Lack of validation data for sanitization cycles

Details

Units Affected
16,971 syringes
Distribution
Nationwide in the USA
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1. Recalled by Central Admixture Pharmacy Services Inc. Units affected: 16,971 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 August 9, 2023. Severity: Moderate. Recall number: D-1078-2023.