Drug 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
D-1216-2014
Product summary
- Event
- Event 67080
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,495 Bags
- Official record key
drug-enforcement:D-1216-2014
Official wording
Reason: 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.
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
Distribution pattern: AZ
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility