D-0745-2017 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
- 17 vials
Product Description
TRI MIX 20/30/2 5ML MDV MCG/MG/MG/1ML INJ, Injection, 20mcg/30mg/2mg/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 # t12-07-2016@97, Exp 5/22/2017; t12-12-2016@88, Exp 5/22/2017; t12-20-2016@109, Exp 5/22/2017; t12-20-2016@119, Exp 6/18/2017; t12-23-2016@63, Exp 6/18/2017; t12-30-2016@84, Exp 6/18/2017; t01-09-2017@97, Exp 6/18/2017; t12-22-2016@120, Exp 6/18/2017; t02-07-2017@72, Exp 8/2/2017