D-0613-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 3, 2016
- Initiation Date
- September 18, 2015
- Termination Date
- June 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 2 Bags, b) 1 Bags, c) 2 Bags, d) 4 Bags, e) 7 Bags f) 3 Bags
Product Description
SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 500ML Homepumps, d) 0.9% in 500ML Homepumps, e) 0.9% in 1500ML Homepumps, f) 0.45% in 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Reason for Recall
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Distribution Pattern
U.S. Including: VA, NC
Code Information
All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 28-Sep-15, 1-Oct-15, b) 22-Sep-15, c) 30-Sep-15 d) 29-Sep-15, e) 25-Sep-15, f) 28-Sep-15