D-1216-2014 Class II Terminated
FDA drug recall D-1216-2014 was initiated by Zions RX Formulations Services LLC dba RX Formuations Serv. on December 12, 2013 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated May 1, 2014). Affected quantity: 1,495 Bags.
Recall Details
- Product Type
- Drugs
- Report Date
- April 16, 2014
- Initiation Date
- December 12, 2013
- Termination Date
- May 1, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,495 Bags
Product Description
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
Reason for Recall
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.
Distribution Pattern
AZ
Code Information
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