FDA-Drug2016-02-03Class II
CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7.3ML Syringes, c) 380MG in 7.6ML Syringes, d) 400MG in 8ML Syringes, e) 460MG in 9.2ML Syringes, f) 475MG in 9.5ML Syringes, g) 500MG in 10ML Syringes, h) 580MG in 116ML Homepumps, i) 600MG in 120ML Homepumps, j) 650MG in 13ML Syringes, k) 800MG in 40ML Homepumps, l) 950MG in 19 mL Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Sentara Enterprises
Hazard
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Sold states
U.S. Including: VA, NC
Affected count
a) 7 Syr, b) 11 Syr, c) 5 Syr, d) 8 Syr, e) 6 Syr, f) 9 Syr, g) 4 Syr, h) 7 Bags, i) 7 Bags, j) 6 Syr, k) 3 Bags l) 4 Syr
Manufactured in
535 Independence Pkwy Ste 300, N/A, Chesapeake, VA, United States
Products
CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7.3ML Syringes, c) 380MG in 7.6ML Syringes, d) 400MG in 8ML Syringes, e) 460MG in 9.2ML Syringes, f) 475MG in 9.5ML Syringes, g) 500MG in 10ML Syringes, h) 580MG in 116ML Homepumps, i) 600MG in 120ML Homepumps, j) 650MG in 13ML Syringes, k) 800MG in 40ML Homepumps, l) 950MG in 19 mL Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0612-2016Don't want to check this manually?
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