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Stop using now Drug recall · FDA · Published September 18, 2015

Sentara Recalls Dextrose-NaCl IV Bags Due to Sterility Risk

Sentara Enterprises recalls specific lots of Dextrose-NaCl (D5-1/2NS) packaged in homepumps due to lack of sterility assurance. Check lot dates if you received this medication.

🇺🇸 FDA recall #D-0620-2016DrugSentara Enterprises ›
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Recalling firmSentara Enterprises535 Independence Pkwy Ste 300 · Chesapeake, VA 23320-5176
✎ GovInfoNow plain-language explainer

What happened, in plain English

Sentara Enterprises is recalling Dextrose-NaCl (D5-1/2NS) intravenous fluids because the manufacturer cannot guarantee that the product remains sterile. The affected bags were packaged in homepumps with volumes of 1700ML, 1800ML, and 1920ML. This recall covers all lots compounded between September 11, 2015, and September 17, 2015. Read more at govinfonow.com/recall/43640-sentara-enterprises-recalls-dextrose-nacl-d5-1-2ns-in-ns.

Source Summary by GovInfoNow · govinfonow.com/recall/43640-sentara-enterprises-recalls-dextrose-nacl-d5-1-2ns-in-ns · Updated October 12, 2026 · FDA enforcement record: FDA #D-0620-2016

Cite this page

“Sentara Recalls Dextrose-NaCl IV Bags Due to Sterility Risk.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/43640-sentara-enterprises-recalls-dextrose-nacl-d5-1-2ns-in-ns. Based on FDA recall #D-0620-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0620-2016%22&limit=1).

Why it’s dangerous

The primary hazard is a lack of assurance of sterility, meaning the product could be contaminated with microorganisms. If non-sterile IV fluid is administered to a patient, it can lead to serious infections or other adverse health effects.

Who’s affected

Patients in Virginia and North Carolina who received prescription Dextrose-NaCl (D5-1/2NS) from Sentara Home Health or Sentara Rx between September 11, 2015, and September 17, 2015. The risk is highest for anyone using these specific compounded bags in homepumps.

How to tell if you have this one

Look for Dextrose-NaCl (D5-1/2NS) in NS packaged in homepumps of 1700ML, 1800ML, or 1920ML. Check the expiration dates: September 25, 2015; September 30, 2015; September 28, 2015; or October 1, 2015. The product was compounded between September 11, 2015, and September 17, 2015.

  • Brand
    Sentara Enterprises
  • Category
    Drug
FDA recall event · 34 products

All 34 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    U.S. Including: VA, NC
Recall numberProduct, codes & lotsQuantity
D-0611-2016MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 18-Sep-15, 20-Sep-15, 21-Sep-15, 22-Sep-15, 23-Sep-15, 24-Sep-15 b) 16-Sep-15, 19-Sep-15, 21-Sep-15a) 159 Bags b) 33 Bags
D-0612-2016CUBICIN (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.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 24-Sep-15, b) 24-Sep-15, 27-Sep-15, c) 26-Sep-15, d) 24-Sep-15, e) 27-Sep-15, f) 26-Sep-15, 27-Sept-15, g) 24-Sep-15, h) 26-Sep-15, i) 27-Sep-15, j) 26-Sep-15, k) 21-Sep-15 l) 24-Sep-15a) 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
D-0613-2016SOD 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.; 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-15a) 2 Bags, b) 1 Bags, c) 2 Bags, d) 4 Bags, e) 7 Bags f) 3 Bags
D-0614-2016Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps, l) 2400ML Homepumps, m) 2650ML Homepumps, n) 2700ML Homepumps, o) 3250ML Homepumps, p) 3390ML Homepumps, and q) 3500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 26-Sep-15, b) 16-Sep-15 c) 25-Sep-15, d) 25-Sep-15 e) 20-Sep-15, 26-Sep-15, f) 20-Sep-15, 24-Sep-15, g) 20-Sep-15, 26-Sep-15, h) 20-Sep-15, i) 15-Sep-15, j) 26-Sep-15, k) 25-Sep-15, 26-Sep-15, l) 20-Sep-15, 23-Sep-15, m) 20-Sept-15, 24-Sep-15, 26-Sep-15, n) 23-Sep-15, o) 20-Sep-15, p) 26-Sep-15, q) 20-Sep-15a) 7, b) 7, c) 6, d) 7, e) 4, f) 13, g) 2, h) 4, i) 7, j) 5, k) 10, l) 11, m) 11, n) 11, o) 7, p) 7, q) 7 Bags
D-0615-2016CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM in 100ML Homepumps, and e) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15, b) 28-Sep-15, 29-Sep-15, c) 30-Sep-15 d) 28-Sep-15, 1-Oct-15 e) 25-Sep-15, 28-Sep-15, 29-Sep-15, 30-Sep-15,1-Oct-15a) 4 Syringes, b) 49 Syringes, c) 18 Bags, d) 80 Bags, e) 23 Bags
D-0616-2016Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d) 104MG in 130ML Homepumps, e) 112MG in 140ML Homepumps, f) 120MG in 150ML Homepumps, g) 124MG in 155ML Homepumps, h) 128MG in 160ML, i) 136MG in 170ML Homepumps, j) 144MG in 180ML Homepumps, k) 152MG in 190ML Homepumps, l) 160MG in 200ML Homepumps, m) 172MG in 215ML Homepumps, n) 176MG in 220ML Homepumps, and o) 200MG in 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15, b) 29-Sep-15, c) 25-Sep-15, 30-Sep-15, d) 25-Sep-15, e) 1-Oct-15, f) 29-Sep-15, g) 26-Sep-15, h) 1-Oct-15, i) 29-Sep-15, j) 25-Sep-15, k) 1-Oct-15, l) 25-Sep-15, m) 27-Sep-15, 1-Oct-15, n) 24-Sep-15, 30-Sep-15, o) 25-Sep-15a) 7, b) 4, c) 8, d) 8, e) 3, f) 4, g) 4, h) 3, i) 4, j) 4, k) 3, l) 3, m) 9, n) 6, o) 3 Bags
D-0617-2016SOLUMEDROL (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.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 22-Sep-15, 23-Sep-157 Bags
D-0618-2016INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 20-Sep-15, c) 24-Sep-15, d) 20-Sep-15, e) 24-Sep-15, f) 26-Sep-15a) 7 Bags, b) 1 Bag, c) 7 Bags, d) 6 Bags e) 7 Bags, f) 7 Bags
D-0619-2016POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 30-Sep-15a) 7 Bags, b) 2 Bags
D-0620-2016Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 30-Sep-15, c) 28-Sep-15, 1-Oct-15a) 1 Bag b) 7 Bags c) 8 Bags
D-0621-2016CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 8GM in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 26-Sep-15, 27-Sep-15, b) 21-Sep-15, 24-Sep-15, 25-Sep-15, 26-Sep-15, 27-Sep-15, c) 25-Sep-15a) 8 Bags, b) 70 Bags c) 4 Bags
D-0622-2016DOBUTAMINE 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.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 25-Sep-15a) 7 Bags, b) 4 Bags
D-0623-2016VANCOMYCIN 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 Homepumps, j) 5000MG in 1000ML Homepumps, k) 6GM in 1200ML Homepumps, l) 7.5GM in 1500ML Homepumps, and m) 9000MG in 1800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 29-Sep-15, 30-Sep-15, b) 25-Sep-15, 29-Sep-15, c) 25-Sep-15 d) 25-Sep-15, 26-Sep-15, 29-Sep-15, e) 25-Sep-15, 1-Oct-15, f) 28-Sep-15, 29-Sep-15, 1-Oct-15, g) 25-Sep-15, h) 25-Sep-15, 27-Sep-15, 29-Sep-15, i) 29-Sep-15, j) 25-Sep-15, 26-Sep-15, k) 29-Sep-15, l) 25-Sep-15, 27-Sep-15, 30-Sep-15, m) 1-Oct-15a) 12 Bags, b) 36 Bags, c) 8 Bags, d) 65 Bags, e) 18 Bags, f) 36 Bags g) 21 Bags, h) 7 Bags, i) 3 Bags, j) 3 Bags, k) 2 Bags, l) 6 Bags, m) 3 Bags
D-0624-2016ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 25-Sep-15, 28-Sep-15, 29-Sep-15, 1-Oct-1577 Bags
D-0625-2016HYDROMORPHONE 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.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 29-Sep-15 b) 30-Sep-15 c) 1-Oct-15, d) 30-Sep-15, e) 30-Sep-15a) 42 Syringes, b) 6 Bags, c) 4 Bags, d) 4 Bags, e) 1 Bag
D-0626-2016GANCICLOVIR 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.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, 1-Oct-15, b) 28-Sep-15a) 22 Bags, b) 3 Bags
D-0627-2016ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 27-Sep-157 Syringes
D-0628-2016Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 22-Sep-15, b) 19-Sep-15, 20-Sep-15, 22-Sep-15, 23-Sep-15, 24-Sep-15, 25-Sep-15a) 3 Bags, b) 60 Bags
D-0629-2016CEFEPIME, 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.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15, b) 30-Sep-15, 1-Oct-15, c) 28-Sep-15a) 21 Bags, b) 26 Bags c) 3 Bags
D-0630-2016ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d) 27GM in 400ML Homepumps, and e) 36GM in 533ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15 b) 28-Sep-15 c) 25-Sep-15, 29-Sep-15, d) 26-Sep-15, 29-Sep-15 e) 1-Oct-15a) 56 Bags b) 28 Bags c) 4 Bags, d) 10 Bags e) 2 Bags
D-0631-2016MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 30-Sep-15a) 5 Bags, b) 4 Bags
D-0632-2016PENICILLIN 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.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 27-Sep-15, b) 28-Sep-15, 30-Sep-15a)1 Bag, b) 4 Bags
D-0633-2016FLUCONAZOLE 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.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 25-Sep-157 Bags
D-0634-2016Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 17-Sep-15, 19-Sep-159 Bags
D-0635-2016Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 27-Sep-1528 Bags
D-0636-2016Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 28-Sep-15 b) 14-Sept-15 c) 1-Oct-15a) 4 Bags b) 3 Bags c) 6 Bags
D-0637-2016Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 30-Sep-157 Bags
D-0638-2016AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 30-Sep-1512 Bags
D-0639-2016CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 29-Sep-156 Bags
D-0640-2016Solu-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.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 28-Sep-15, 30-Sep-159 Bags
D-0641-2016GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 25-Sep-15, c) 24-Sep-15a) 11 bags, b) 9 Bags, c) 3 Bags
D-0642-2016Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 29-Sep-151 Bag
D-0643-2016Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 28-Sep-157 Bags
D-0644-2016MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.; All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 24-Sep-15, 27-Sep-1510 Bags
Based on the official FDA remedy

What to do — step by step

  1. Stop using the medication

    Do not administer the recalled Dextrose-NaCl bags if you have them in your possession.

  2. Contact your healthcare provider

    Reach out to Sentara Home Health or Sentara Rx immediately for instructions on how to return or dispose of the product and obtain a replacement.

Where it went and when

Where it was distributed

Distributed in North Carolina and Virginia.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “U.S. Including: VA, NC” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: North Carolina, Virginia.

Recall timeline

FDA terminated this recall 9 months after the firm started it.

1. Firm started the recall: Sep 18, 201512. FDA classified it Class II: Jan 28, 201623. Published in FDA’s Enforcement Report: Feb 3, 201634. FDA terminated the recall: Jun 29, 2016420152016
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0620-2016 (September 18, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0620-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA