D-1176-2016 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
- 8500 mL in Vials
Product Description
CALCIUM SODIUM EDTA 300MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S. Nationwide, Japan, and New Zealand.
Code Information
Lot # : 151123-11, BUD: 05/21/16; Lot #: 160105-24, BUD: 07/03/16; Lot #: 160118-7, BUD: 07/16/16