D-0204-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 12, 2014
- Initiation Date
- October 6, 2014
- Termination Date
- June 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 119/0.3 mL vials and 106/1 mL vials
Product Description
METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Reason for Recall
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Distribution Pattern
Oregon, Washington
Code Information
Lot #: 20140718@2/0.3, discard date: 1/14/2015; Lot #: 20140808@4/0.3, discard date: 2/4/2015; Lot #: 20140902@36/1, discard date: 3/1/2015; Lot #: 20140902@37/0.3, discard date: 3/1/2015; Lot #: 20140912@22/1, discard date: 3/11/2015.