Recalls / Class II
Class IID-0620-2016
Product
Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Affected lot / code info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 30-Sep-15, c) 28-Sep-15, 1-Oct-15
Why it was recalled
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recalling firm
- Firm
- Sentara Enterprises
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 535 Independence Pkwy Ste 300, N/A, Chesapeake, Virginia 23320-5176
Distribution
- Quantity
- a) 1 Bag b) 7 Bags c) 8 Bags
- Distribution pattern
- U.S. Including: VA, NC
Timeline
- Recall initiated
- 2015-09-18
- FDA classified
- 2016-01-28
- Posted by FDA
- 2016-02-03
- Terminated
- 2016-06-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0620-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.