Drug recall: ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
Class II FDA enforcement event 69519. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II, in the words of FDA
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
Oregon Compounding Centers, Inc. dba Creative Compounds started this drug recall on 6 Oct 2014. The firm address in the FDA record is in Wilsonville, OR. FDA put the recall in Class II. FDA event 69519 has 56 product records. The first FDA enforcement report date is 12 Nov 2014. The record gives the status Terminated, with the termination date 30 Jun 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Oregon, Washington
Recalling firm
Oregon Compounding Centers, Inc. dba Creative Compounds, Wilsonville, OR.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
56 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0173-2015 | ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. | 5 mL | Class II | Terminated | 12 Nov 2014 |
| D-0174-2015 | ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. | 5 mL | Class II | Terminated | 12 Nov 2014 |
| D-0175-2015 | ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. | 2500 mL | Class II | Terminated | 12 Nov 2014 |
| D-0176-2015 | ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. | 7900 mL | Class II | Terminated | 12 Nov 2014 |
| D-0177-2015 | AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070. | 5483/0.5 mL syringes | Class II | Terminated | 12 Nov 2014 |
| D-0178-2015 | BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070. | 2.65 mL | Class II | Terminated | 12 Nov 2014 |
| D-0179-2015 | CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 580 mL | Class II | Terminated | 12 Nov 2014 |
| D-0180-2015 | CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 | 12 syringes | Class II | Terminated | 12 Nov 2014 |
| D-0181-2015 | CHORIONIC GONADOTROPIN, 4000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 145 vials | Class II | Terminated | 12 Nov 2014 |
| D-0182-2015 | CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 117 vials | Class II | Terminated | 12 Nov 2014 |
| D-0183-2015 | CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 | 900 mL | Class II | Terminated | 12 Nov 2014 |
| D-0184-2015 | COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 600 mL | Class II | Terminated | 12 Nov 2014 |
| D-0185-2015 | DEXAMETHASONE (AS SOD PHOS), 24 mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 4 mL | Class II | Terminated | 12 Nov 2014 |
| D-0186-2015 | DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 210 mL | Class II | Terminated | 12 Nov 2014 |
| D-0187-2015 | DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 280 mL | Class II | Terminated | 12 Nov 2014 |
| D-0188-2015 | EPINEPHRINE/WATER, preservative free 1:1000, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 10 mL | Class II | Terminated | 12 Nov 2014 |
| D-0189-2015 | ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 4 mL | Class II | Terminated | 12 Nov 2014 |
| D-0190-2015 | GANCICLOVIR -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 | 40 syringes | Class II | Terminated | 12 Nov 2014 |
| D-0191-2015 | GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 | 20 Syringes | Class II | Terminated | 12 Nov 2014 |
| D-0192-2015 | GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070 | 800 mL | Class II | Terminated | 12 Nov 2014 |
| D-0193-2015 | GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070 | 300 mL | Class II | Terminated | 12 Nov 2014 |
| D-0194-2015 | GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070 | 250 mL | Class II | Terminated | 12 Nov 2014 |
| D-0195-2015 | GLUTATHIONE with preservative, 100mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 2200 mL | Class II | Terminated | 12 Nov 2014 |
| D-0196-2015 | GLUTATHIONE, 100 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 900 mL | Class II | Terminated | 12 Nov 2014 |
| D-0197-2015 | HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 10 mL | Class II | Terminated | 12 Nov 2014 |
| D-0198-2015 | HYDROXOCOBALAMIN-preservative free (B12), 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 58 mL | Class II | Terminated | 12 Nov 2014 |
| D-0199-2015 | HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 570 mL | Class II | Terminated | 12 Nov 2014 |
| D-0200-2015 | HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 520 mL | Class II | Terminated | 12 Nov 2014 |
| D-0201-2015 | LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070 | 49/5 mL bottles; 40/6 mL bottles; 30/7 ml bottles | Class II | Terminated | 12 Nov 2014 |
| D-0202-2015 | METHYCOBALAMIN, preservative free, 10mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 120 mL | Class II | Terminated | 12 Nov 2014 |
| D-0203-2015 | METHYCOBALAMIN, preservative free, 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 516 mL | Class II | Terminated | 12 Nov 2014 |
| D-0204-2015 | METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 119/0.3 mL vials and 106/1 mL vials | Class II | Terminated | 12 Nov 2014 |
| D-0205-2015 | METHYCOBALAMIN, preservative, 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 1320 mL | Class II | Terminated | 12 Nov 2014 |
| D-0206-2015 | MITOMYCIN, 0.2mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 5 mL | Class II | Terminated | 12 Nov 2014 |
| D-0207-2015 | MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 8 mL | Class II | Terminated | 12 Nov 2014 |
| D-0208-2015 | OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 680 mL | Class II | Terminated | 12 Nov 2014 |
| D-0209-2015 | PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 25 mL | Class II | Terminated | 12 Nov 2014 |
| D-0210-2015 | PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 43 mL | Class II | Terminated | 12 Nov 2014 |
| D-0211-2015 | PAPAVERINE HCL, with preservative, 30 mg/mL, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 5 mL | Class II | Terminated | 12 Nov 2014 |
| D-0212-2015 | PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 10 mL | Class II | Terminated | 12 Nov 2014 |
| D-0213-2015 | PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 46.7 mL | Class II | Terminated | 12 Nov 2014 |
| D-0214-2015 | PAPAVERINE HCL/PHENTOLAMINE/PROSTAGLANDIN, 27.7mg/0.45mg/45.45mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 5 mL | Class II | Terminated | 12 Nov 2014 |
| D-0215-2015 | PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 15 mL | Class II | Terminated | 12 Nov 2014 |
| D-0216-2015 | PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 103.4 mL | Class II | Terminated | 12 Nov 2014 |
| D-0217-2015 | PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.44mg/0.64mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 10 mL | Class II | Terminated | 12 Nov 2014 |
| D-0218-2015 | PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 1.7 mL | Class II | Terminated | 12 Nov 2014 |
| D-0219-2015 | PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070 | 10 mL | Class II | Terminated | 12 Nov 2014 |
| D-0220-2015 | PROCAINE HCL (BUFF), 1%, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 540 mL | Class II | Terminated | 12 Nov 2014 |
| D-0221-2015 | PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 660 mL | Class II | Terminated | 12 Nov 2014 |
| D-0222-2015 | SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, RX, Creative Compounds, Wilsonville, OR 97070 | 180 mL | Class II | Terminated | 12 Nov 2014 |
| D-0223-2015 | TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 175 mL | Class II | Terminated | 12 Nov 2014 |
| D-0224-2015 | TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | 85 mL | Class II | Terminated | 12 Nov 2014 |
| D-0225-2015 | TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070 | 1000 mL | Class II | Terminated | 12 Nov 2014 |
| D-0226-2015 | TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 | 2 syringes | Class II | Terminated | 12 Nov 2014 |
| D-0227-2015 | VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 | 12 syringes | Class II | Terminated | 12 Nov 2014 |
| D-0228-2015 | VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. | 490 mL | Class II | Terminated | 12 Nov 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2014
- 313
- Share of these events in Class II
- 58%
- Product records in this event
- 56
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-0173-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 69519. https://recallregister.com/fda/ii/69519/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Oregon, Washington
- What quantity of product is in FDA event 69519?
- The event has 56 product records. The first record gives this quantity:
5 mL
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2014 have the same class?
- 58% of the 313 drug events that started in 2014 are in Class II.