D-0737-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 24, 2017
- Initiation Date
- April 18, 2017
- Termination Date
- August 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 vials
Product Description
TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
Reason for Recall
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Distribution Pattern
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # 11-18-2016@70, Exp 4/19/2017; 11-23-2016@84, Exp 5/22/2017; t12-14-2016@99, Exp 5/22/2017; t01-03-2017@94, Exp 6/18/2017; 01-13-2017@71, Exp 7/5/2017; 01-25-2017@103, Exp 7/5/2017; 02-06-2017@94, Exp 7/5/2017; t02-17-2017@87, Exp 8/2/2017.