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FDA Drug Recalls

14,450 recalls · Class II, newest first

Class II · Moderate risk Terminated Sep 18, 2015

Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy…

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

Sentara Enterprises D-0634-2016

Class II · Moderate risk Terminated Sep 18, 2015

FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy…

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

Sentara Enterprises D-0633-2016

Class II · Moderate risk Terminated Sep 18, 2015

PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX…

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

Sentara Enterprises D-0632-2016

Class II · Moderate risk Terminated Sep 18, 2015

MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535…

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

Sentara Enterprises D-0631-2016

Class II · Moderate risk Terminated Sep 18, 2015

ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML…

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

Sentara Enterprises D-0630-2016

Class II · Moderate risk Terminated Sep 18, 2015

CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME…

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

Sentara Enterprises D-0629-2016

Class II · Moderate risk Terminated Sep 18, 2015

Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Homepumps, Rx Only…

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

Sentara Enterprises D-0628-2016

Class II · Moderate risk Terminated Sep 18, 2015

ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300…

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

Sentara Enterprises D-0627-2016

Class II · Moderate risk Terminated Sep 18, 2015

GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA…

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

Sentara Enterprises D-0626-2016

Class II · Moderate risk Terminated Sep 18, 2015

HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in…

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

Sentara Enterprises D-0625-2016

Class II · Moderate risk Terminated Sep 18, 2015

ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300…

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

Sentara Enterprises D-0624-2016

Class II · Moderate risk Terminated Sep 18, 2015

VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in…

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

Sentara Enterprises D-0623-2016

Class II · Moderate risk Terminated Sep 18, 2015

DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTARA HOME HEALTH…

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

Sentara Enterprises D-0622-2016

Class II · Moderate risk Terminated Sep 18, 2015

CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 8GM in 200ML Homepumps, Rx Only…

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

Sentara Enterprises D-0621-2016

Class II · Moderate risk Terminated Sep 18, 2015

Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA…

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

Sentara Enterprises D-0620-2016

Class II · Moderate risk Terminated Sep 18, 2015

POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500ML Homepumps, Rx…

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

Sentara Enterprises D-0619-2016

Class II · Moderate risk Terminated Sep 18, 2015

INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML…

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

Sentara Enterprises D-0618-2016

Class II · Moderate risk Terminated Sep 18, 2015

SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535…

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

Sentara Enterprises D-0617-2016

Class II · Moderate risk Terminated Sep 18, 2015

Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d) 104MG in…

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

Sentara Enterprises D-0616-2016

Class II · Moderate risk Terminated Sep 18, 2015

CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM in 100ML Homepumps…

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

Sentara Enterprises D-0615-2016

Class II · Moderate risk Terminated Sep 18, 2015

Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML…

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

Sentara Enterprises D-0614-2016

Class II · Moderate risk Terminated Sep 18, 2015

SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 500ML Homepumps, d)…

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

Sentara Enterprises D-0613-2016

Class II · Moderate risk Terminated Sep 18, 2015

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…

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

Sentara Enterprises D-0612-2016

Class II · Moderate risk Terminated Sep 18, 2015

MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA…

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

Sentara Enterprises D-0611-2016

Class II · Moderate risk Terminated Sep 17, 2015

WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large Patches, Distributed by Consignor…

Reason Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except…

The Mentholatum Co. NDC 10742-8126-2 D-0018-2016