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- Recall Enforcement Event ID: 72746
Recall Enforment Report D-0616-2016
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Sentara Enterprises, originally initiated on 09-18-2015 for the product 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 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. The product was recalled due to lack of assurance of sterility: product sterility cannot be guaranteed.. The product was distributed in U.s. Including: Va, Nc and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0616-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 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 | 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 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0628-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 3 Bags, b) 60 Bags | Invanz (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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0644-2016 | 09-18-2015 | 02-03-2016 | Class II | 10 Bags | MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0630-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 56 Bags b) 28 Bags c) 4 Bags, d) 10 Bags e) 2 Bags | ZOSYN (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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0641-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 11 bags, b) 9 Bags, c) 3 Bags | GENTAMICIN, 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0632-2016 | 09-18-2015 | 02-03-2016 | Class II | a)1 Bag, b) 4 Bags | 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0635-2016 | 09-18-2015 | 02-03-2016 | Class II | 28 Bags | Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0633-2016 | 09-18-2015 | 02-03-2016 | Class II | 7 Bags | 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0637-2016 | 09-18-2015 | 02-03-2016 | Class II | 7 Bags | Cancidas (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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0626-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 22 Bags, b) 3 Bags | 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0631-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 5 Bags, b) 4 Bags | MORPHINE 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0623-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 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 | 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 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0625-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 42 Syringes, b) 6 Bags, c) 4 Bags, d) 4 Bags, e) 1 Bag | HYDROMORPHONE 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0615-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 4 Syringes, b) 49 Syringes, c) 18 Bags, d) 80 Bags, e) 23 Bags | CEFAZOLIN, 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0613-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 2 Bags, b) 1 Bags, c) 2 Bags, d) 4 Bags, e) 7 Bags f) 3 Bags | SOD 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0614-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 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 | Parenteral 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0621-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 8 Bags, b) 70 Bags c) 4 Bags | CEFTRIAXONE 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0636-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 4 Bags b) 3 Bags c) 6 Bags | Lactated 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0638-2016 | 09-18-2015 | 02-03-2016 | Class II | 12 Bags | AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0617-2016 | 09-18-2015 | 02-03-2016 | Class II | 7 Bags | 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0618-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 7 Bags, b) 1 Bag, c) 7 Bags, d) 6 Bags e) 7 Bags, f) 7 Bags | INTRALIPID (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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0612-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 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 | 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 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0620-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 1 Bag b) 7 Bags c) 8 Bags | Dextrose-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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0634-2016 | 09-18-2015 | 02-03-2016 | Class II | 9 Bags | Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0642-2016 | 09-18-2015 | 02-03-2016 | Class II | 1 Bag | Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0627-2016 | 09-18-2015 | 02-03-2016 | Class II | 7 Syringes | ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0622-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 7 Bags, b) 4 Bags | 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0611-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 159 Bags b) 33 Bags | MEROPENEM 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0624-2016 | 09-18-2015 | 02-03-2016 | Class II | 77 Bags | ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0643-2016 | 09-18-2015 | 02-03-2016 | Class II | 7 Bags | Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0640-2016 | 09-18-2015 | 02-03-2016 | Class II | 9 Bags | 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0629-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 21 Bags, b) 26 Bags c) 3 Bags | 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. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0619-2016 | 09-18-2015 | 02-03-2016 | Class II | a) 7 Bags, b) 2 Bags | 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 Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
| D-0639-2016 | 09-18-2015 | 02-03-2016 | Class II | 6 Bags | CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Terminated |
Recall Enforcement Report D-0616-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0616-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 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 Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- 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-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0628-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0628-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Invanz (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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 3 Bags, b) 60 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- 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-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0644-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0644-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 10 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 24-Sep-15, 27-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0630-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0630-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ZOSYN (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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 56 Bags b) 28 Bags c) 4 Bags, d) 10 Bags e) 2 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- 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-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0641-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0641-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- GENTAMICIN, 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 11 bags, b) 9 Bags, c) 3 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 25-Sep-15, c) 24-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0632-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0632-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a)1 Bag, b) 4 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 27-Sep-15, b) 28-Sep-15, 30-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0635-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0635-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 28 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 27-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0633-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0633-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 25-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0637-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0637-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Cancidas (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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 30-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0626-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0626-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 22 Bags, b) 3 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, 1-Oct-15, b) 28-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0631-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0631-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MORPHINE 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 5 Bags, b) 4 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 30-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0623-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0623-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 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 Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- 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-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0625-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0625-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HYDROMORPHONE 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 42 Syringes, b) 6 Bags, c) 4 Bags, d) 4 Bags, e) 1 Bag Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- 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-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0615-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0615-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- CEFAZOLIN, 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 4 Syringes, b) 49 Syringes, c) 18 Bags, d) 80 Bags, e) 23 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- 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-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0613-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0613-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- SOD 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 2 Bags, b) 1 Bags, c) 2 Bags, d) 4 Bags, e) 7 Bags f) 3 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- 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-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0614-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0614-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Parenteral 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 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 Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- 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-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0621-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0621-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- CEFTRIAXONE 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 8 Bags, b) 70 Bags c) 4 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- 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-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0636-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0636-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Lactated 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 4 Bags b) 3 Bags c) 6 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 28-Sep-15 b) 14-Sept-15 c) 1-Oct-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0638-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0638-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 12 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 30-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0617-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0617-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 22-Sep-15, 23-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0618-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0618-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- INTRALIPID (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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 7 Bags, b) 1 Bag, c) 7 Bags, d) 6 Bags e) 7 Bags, f) 7 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- 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-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0612-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0612-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 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 Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- 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-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0620-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0620-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Dextrose-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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 1 Bag b) 7 Bags c) 8 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- 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-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0634-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0634-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 9 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 17-Sep-15, 19-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0642-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0642-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 Bag Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 29-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0627-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0627-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7 Syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 27-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0622-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0622-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 7 Bags, b) 4 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 25-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0611-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0611-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MEROPENEM 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 159 Bags b) 33 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- 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-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0624-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0624-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 77 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 25-Sep-15, 28-Sep-15, 29-Sep-15, 1-Oct-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0643-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0643-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 28-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0640-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0640-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 9 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 28-Sep-15, 30-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0629-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0629-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 21 Bags, b) 26 Bags c) 3 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- 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-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0619-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0619-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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 Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 7 Bags, b) 2 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 30-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0639-2016
- Event ID
- 72746 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0639-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Including: VA, NC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Reason For Recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 6 Bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-03-2016
- Recall Initiation Date
- 09-18-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-29-2016 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Sentara Enterprises
- Code Info
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 29-Sep-15 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
