Sentara Enterprises
Sentara Enterprises appears in FDA public data with 34 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0616-2016, Class II) was initiated on September 18, 2015.
Summary
- Total Recalls
- 34
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0616-2016 | Class II | Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in | September 18, 2015 |
| D-0632-2016 | Class II | PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SE | September 18, 2015 |
| D-0644-2016 | Class II | MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTAR | September 18, 2015 |
| D-0630-2016 | Class II | ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML H | September 18, 2015 |
| D-0623-2016 | Class II | VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 1 | September 18, 2015 |
| D-0637-2016 | Class II | Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only. SENTARA HOME HE | September 18, 2015 |
| D-0615-2016 | Class II | CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps | September 18, 2015 |
| D-0613-2016 | Class II | SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0 | September 18, 2015 |
| D-0614-2016 | Class II | Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML H | September 18, 2015 |
| D-0621-2016 | Class II | CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 8GM in 20 | September 18, 2015 |
| D-0638-2016 | Class II | AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, | September 18, 2015 |
| D-0627-2016 | Class II | ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 | September 18, 2015 |
| D-0617-2016 | Class II | SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA H | September 18, 2015 |
| D-0618-2016 | Class II | INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d | September 18, 2015 |
| D-0622-2016 | Class II | DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx O | September 18, 2015 |
| D-0611-2016 | Class II | MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. S | September 18, 2015 |
| D-0624-2016 | Class II | ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Indep | September 18, 2015 |
| D-0620-2016 | Class II | Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML | September 18, 2015 |
| D-0634-2016 | Class II | Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA R | September 18, 2015 |
| D-0642-2016 | Class II | Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independ | September 18, 2015 |