FDA-Drug2023-08-09Class II

PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1

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
10,494 syringes
Manufactured in
7935 Dunbrook Rd Ste C, N/A, San Diego, CA, United States
Products
PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1077-2023

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