FDAFDA · Food and drugs·Recall number D-1216-2014
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
Published April 16, 2014 · Recall initiated: December 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zions RX Formulations Services LLC dba RX Formuations Serv.
- Distributor
- AZ
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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