Isovue 200 mg/mL PF and 300 mg/mL PF recall: Sterility Concern
Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
Why was Isovue 200 mg/mL PF and 300 mg/mL PF recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lot codes
- Product
- Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
- Recalling firm
- New England Compounding Center
- Quantity
- 7055 vials
- Distribution
- Nationwide
- Recall date
- January 9, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)