D-0618-2016 Class II Terminated
FDA drug recall D-0618-2016 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) 7 Bags, b) 1 Bag, c) 7 Bags, d) 6 Bags e) 7 Bags, f) 7 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) 7 Bags, b) 1 Bag, c) 7 Bags, d) 6 Bags e) 7 Bags, f) 7 Bags
Product Description
INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML 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) 25-Sep-15, b) 20-Sep-15, c) 24-Sep-15, d) 20-Sep-15, e) 24-Sep-15, f) 26-Sep-15