FDA (Drugs) recall action 72746

Sentara Enterprises recalled 34 products on 2016-02-03

The FDA (Drugs) publishes a recall like this one as 34 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 34 pages.

Products: 34
Announced: 2016-02-03
Critical: 0
Units: 187

Why these products were recalled

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

26–34 of 34

SevereFDA (Drugs)··2016-02-03
Sentara Recalls Ascorbic Acid Syringes Due to Sterility Concerns
Sentara Enterprises is recalling 7 syringes of Ascorbic Acid 500mg because the product's sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.
Product
ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Distribution
2 states
SevereFDA (Drugs)··2016-02-03
Sentara Recalls Penicillin in D5W Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Penicillin in D5W Homepumps because the sterility of the product cannot be guaranteed.
Product
PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Distribution
2 states
SevereFDA (Drugs)··2016-02-03
Sentara Recalls Solu-Cortef Syringes Due to Sterility Concerns
Sentara Enterprises is recalling 9 bags of Solu-Cortef (hydrocortisone) 1MG in NS syringes because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.
Product
Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Distribution
2 states
SevereFDA (Drugs)··2016-02-03
Sentara Recalls Vancomycin HCL Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling Vancomycin HCL home infusion bags because the product's sterility cannot be guaranteed. The recall affects bags distributed in Virginia and North Carolina.
Product
VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepumps, e) 1.25GM in 250ML Homepumps, f) 1.5GM in 300ML Homepumps, g) 1.75GM in 350ML Homepumps, h) 2GM in 400ML Homepumps, i) 4000MG in 800ML Ho
Category
Distribution
2 states
SevereFDA (Drugs)··2016-02-03
Sentara Recalls Solumedrol Bags Due to Sterility Assurance Concerns
Sentara Enterprises is recalling 7 bags of Solumedrol (methylprednisolone succinate) 1GM in NS because product sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.
Product
SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Distribution
2 states
SevereFDA (Drugs)··2016-02-03
Sentara Recalls Dobutamine HCL Infusions Due to Sterility Concerns
Sentara Enterprises is recalling Dobutamine HCL in D5W home infusion bags because the sterility of the product cannot be guaranteed.
Product
DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Distribution
2 states
SevereFDA (Drugs)··2016-02-03
Sentara Recalls Cefepime Homepumps Due to Sterility Assurance Concerns
Sentara Enterprises is recalling specific lots of Cefepime Homepumps because the sterility of the product cannot be guaranteed.
Product
CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Distribution
2 states
SevereFDA (Drugs)··2016-02-03
Sentara Recalls Fluconzole Bags Due to Sterility Assurance Issues
Sentara Enterprises is recalling 7 bags of Fluconzole in NaCl 400mg because product sterility cannot be guaranteed. The affected lots were distributed in Virginia and North Carolina.
Product
FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Distribution
2 states
SevereFDA (Drugs)··2016-02-03
Sentara Recalls Ganciclovir Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Ganciclovir in NS Homepumps because product sterility cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.
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.
Category
Distribution
2 states