D-1228-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 20, 2016
- Initiation Date
- May 13, 2016
- Termination Date
- June 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 157,500 mL in Vials
Product Description
NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S. Nationwide, Japan, and New Zealand.
Code Information
a) Lot #: 151217-47, BUD: 06/14/16; Lot #: 160112-51, BUD: 07/10/16; Lot #: 160127-43, BUD: 07/25/16; Lot #: 160218-8, BUD: 08/16/16; Lot #: 151211-26, BUD: 06/08/16. b) Lot #: 151211-26, BUD: 06/08/16; Lot #: 151217-47, BUD: 06/14/16; Lot #: 160112-51, BUD: 07/10/16; Lot #: 160127-43, BUD: 07/25/16; Lot #: 160218-8, BUD: 08/16/16. c) Lot #: 151211-26, BUD: 06/08/16; Lot #: 160112-51, BUD: 07/10/16; Lot #: 160127-43, BUD: 07/25/16; Lot #: 151217-47, BUD: 06/14/16; Lot #: 160218-8, BUD: 08/16/16.