CLASS II Drug recall · Reported 12 Nov 2014 · FDA Enforcement Report
Tobramycin, 480mg/, solution for irrigation, RX recalled
Oregon Compounding Centers is recalling Tobramycin, 480mg/, solution for irrigation, RX, Creative Compounds, Wilsonville, OR 97070, distributed in Oregon, Washington. The recall was initiated on 6 Oct 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0225-2015
- FDA event ID
- 69519
- Recalling firm
- Oregon Compounding Centers, Wilsonville, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Oct 2014
- FDA classified
- 31 Oct 2014
- Reported
- 12 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Foreign Material
- Drug class
- Compounded Drugs
Timeline
| 6 Oct 2014 | Recall initiated by company | |
| 31 Oct 2014 | Classified by FDA | +25 days |
| 12 Nov 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
Where it was distributed
Oregon, Washington
Questions about this recall
Is Tobramycin, 480mg/, solution for irrigation, RX, Creative Compounds, Wilsonville, OR 97070 recalled?
Yes. Oregon Compounding Centers recalled Tobramycin, 480mg/, solution for irrigation, RX, Creative Compounds, Wilsonville, OR 97070 on 6 Oct 2014. The recall is Class II and its status is Terminated. Recall number D-0225-2015.
Why was it recalled?
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
Which lots are affected?
Lot #: 20140912@16, discard date: 10/17/2014
Where was it sold?
Oregon, Washington
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Oregon Compounding Centers
All 56| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Chloride Inhalation, 7%, Solution recalled | Oregon Compounding Centers | Foreign Material | OR, WA |
| Drug | CLASS II | Papaverine HCL/Phentolamine/Alprostadil, 82mg/0.91mg/45mcg recalled | Oregon Compounding Centers | Foreign Material | OR, WA |
| Drug | CLASS II | Avastin, 25mg/, injectable plastic syringe, RX recalled | Oregon Compounding Centers | Foreign Material | OR, WA |
| Drug | CLASS II | Gentamicin Sulfate, 100mg/, solution for irrigation, RX recalled | Oregon Compounding Centers | Foreign Material | OR, WA |
| Drug | CLASS II | Calcium Chloride (Compound), 100 mg/mL recalled | Oregon Compounding Centers | Foreign Material | OR, WA |