Recalls / Class II
Class IID-0613-2016
Product
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.
- Affected lot / code info
- 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
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) 2 Bags, b) 1 Bags, c) 2 Bags, d) 4 Bags, e) 7 Bags f) 3 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-0613-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.