Recalls / Class II
Class IID-0626-2016
Product
GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML 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, 1-Oct-15, b) 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) 22 Bags, b) 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-0626-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.