Drug product
Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
D-1219-2014
Product summary
- Event
- Event 67080
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38 units
- Official record key
drug-enforcement:D-1219-2014
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: a) Lot#118954@2 Exp. Date: 03/09/2014, Lot# 118917@2 Exp. Date: 03/06/2014; b) Lot #: 119379@24 Exp. Date: 01/19/2014, Lot#: 118815@27 Exp. Date: 03/03/2014
Distribution pattern: AZ
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility