D-0281-2017 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 11, 2017
- Initiation Date
- November 17, 2016
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 vials
Product Description
Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide
Code Information
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06162016B (07/17/2016).