D-0630-2016 Class II Terminated
FDA drug recall D-0630-2016 was initiated by Sentara Enterprises on September 18, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Product sterility cannot be guaranteed. The recall status is terminated (terminated June 29, 2016). Affected quantity: a) 56 Bags b) 28 Bags c) 4 Bags, d) 10 Bags e) 2 Bags.
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) 56 Bags b) 28 Bags c) 4 Bags, d) 10 Bags e) 2 Bags
Product Description
ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d) 27GM in 400ML Homepumps, and e) 36GM in 533ML 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) 1-Oct-15 b) 28-Sep-15 c) 25-Sep-15, 29-Sep-15, d) 26-Sep-15, 29-Sep-15 e) 1-Oct-15