Drug product
Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
D-1215-2014
Product summary
- Event
- Event 67080
- Status
- Terminated
- Classification
- Class II
- Quantity
- 95 Vials
- Official record key
drug-enforcement:D-1215-2014
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 #: 117467@9 Expiration Date: 12/12/2013 Lot #: 117857@2 Expiration Date: 12/15/2013 Lot #: 117740@4 Expiration Date: 12/13/2013
Distribution pattern: AZ
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility