Drug product
Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
D-1214-2014
Product summary
- Event
- Event 67080
- Status
- Terminated
- Classification
- Class II
- Quantity
- 861 Bags
- Official record key
drug-enforcement:D-1214-2014
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 #: 117037@3 Expiration Date: 12/13/2013 Lot #: 117899@1 Expiration Date: 01/03/2014 Lot #: 118289@7 Expiration Date: 01/09/2014 Lot #: 118078@56 Expiration Date: 01/03/2014 Lot #:118394@29 Expiration Date: 01/09/2014 Lot #: 118338@10 Expiration Date: 01/09/2014 Lot #: 118056@46 Expiration Date: 01/02/2014
Distribution pattern: AZ
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility