D-0710-2017 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
- 63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial)
Product Description
5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, 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 # t12-05-2016@116, Exp 6/4/2017; t12-15-2016@84, Exp 6/14/2017; t12-23-2016@67, Exp 6/25/2017; t12-28-2016@105, Exp 6/27/2017; t01-30-2017@88, Exp 7/30/2017; t02-06-2017@109, Exp 8/6/2017; t02-14-2017@92, Exp 8/14/2017; t02-20-2017@79, Exp 8/20/2017