FDA-Drug2023-08-09Class II

fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2

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
896 bags
Manufactured in
7935 Dunbrook Rd Ste C, N/A, San Diego, CA, United States
Products
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1072-2023

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