D-1219-2014 Class II Terminated
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
- 38 units
Product Description
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
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
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