Recalls / Class II

Class IID-1216-2014

Product

Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205

Affected lot / code info

Lot #: 117440@1 Expiration Date: 12/27/2013 Lot #: 117901@2 Expiration Date: 01/03/2014 Lot #: 118291@32 Expiration Date: 01/05/2014 Lot #: 118392@28 Expiration Date: 01/09/2014 Lot #: 117659@66 Expiration Date: 12/26/2013 Lot #: 118348@17 Expiration Date: 01/09/2014 Lot #: 117601@38 Expiration Date: 12/26/2013 Lot #: 117847@13 Expiration Date: 12/29/2013 Lot #: 118058@47 Expiration Date: 01/02/2014

Why it was recalled

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.

Recalling firm

Firm

Zions RX Formulations Services LLC dba RX Formuations Serv.

Notification channel

E-Mail

Type

Voluntary: Firm initiated

Address

5949 E University Dr, N/A, Mesa, Arizona 85205-7435

Distribution

Quantity

1,495 Bags

Distribution pattern

AZ

Timeline

Recall initiated

2013-12-12

FDA classified

2014-04-07

Posted by FDA

2014-04-16

Terminated

2014-05-01

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1216-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.