Sentara Enterprises
Complete recall history across all FDA and CPSC categories — 34 total recalls
Sentara Enterprises appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (34)
FDA drug safety enforcement actions by Sentara Enterprises
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 18, 2015 | MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Home... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in ... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTAR... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homep... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALT... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100M... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps,... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps,... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG i... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepu... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, R... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML H... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepum... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SEN... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH S... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTAR... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 48... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. S... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML H... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME ... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100M... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA ... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEA... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA ... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Hom... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
| Sep 18, 2015 | Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML H... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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