FDA-Drug2014-04-16Class II

Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205

Zions RX Formulations Services LLC dba RX Formuations Serv.
Hazard

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Sold states
AZ
Affected count
38 units
Manufactured in
5949 E University Dr, N/A, Mesa, AZ, United States
Products
Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1219-2014

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