D-1191-2016 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
- 800 mL in Vials
Product Description
HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S. Nationwide, Japan, and New Zealand.
Code Information
a) Lot #: 160119-8, BUD: 07/17/16; Lot #: 160204-30, BUD: 08/02/16. b) Lot #: 160119-8, BUD: 07/17/16; Lot #: 160204-30, BUD: 08/02/16.