D-0760-2017 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
- 1 vial
Product Description
CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx only, 10mL 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 # t02-06-2017@107, Exp 4/30/2017 Lot t02-06-2017@107, Expiry date 4/30/2017