CLASS II Drug recall · Reported 9 Jan 2013 · FDA Enforcement Report
Isovue 200 mg/mL PF and 300 mg/mL PF, Vials recalled
New England Compounding Center is recalling Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, distributed nationwide in the US. The recall was initiated on 26 Sep 2012 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-119-2013
- FDA event ID
- 63305
- Recalling firm
- New England Compounding Center, Framingham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Sep 2012
- FDA classified
- 31 Dec 2012
- Reported
- 9 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Sep 2012 | Recall initiated by company | |
| 31 Dec 2012 | Classified by FDA | +96 days |
| 9 Jan 2013 | Published in enforcement report | +9 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 Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
Where it was distributed
Nationwide
Questions about this recall
Is Isovue 200 mg/mL PF and 300 mg/mL PF, Vials recalled?
Yes. New England Compounding Center recalled Isovue 200 mg/mL PF and 300 mg/mL PF, Vials on 26 Sep 2012. The recall is Class II and its status is Terminated. Recall number D-119-2013.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
All lot codes
Where was it sold?
Nationwide
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 New England Compounding Center
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hyaluronidase 150 u/ml PF, and vials recalled | New England Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Dexamethasone Sodium Phosphate 4 mg/mL vials PF recalled | New England Compounding Center | Sterility | Nationwide |
| Drug | CLASS I | Methylprednisolone Acetate 80 mg/mL Injection, Preserved recalled | New England Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Lidocaine/Dextrose 5%/7.5% PF recalled by New England Compounding Center | New England Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Clonidine 100 mcg/mL PF and vials recalled | New England Compounding Center | Sterility | Nationwide |