FDA-Drug2016-02-03Class II

HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e) 135MG in 135ML Homepumps, 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) 42 Syringes, b) 6 Bags, c) 4 Bags, d) 4 Bags, e) 1 Bag
Manufactured in
535 Independence Pkwy Ste 300, N/A, Chesapeake, VA, United States
Products
HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e) 135MG in 135ML Homepumps, 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-0625-2016

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