New England Compounding Center Recalls Isovue Vials Due to Sterility Concerns
New England Compounding Center is recalling Isovue 200 mg/mL and 300 mg/mL vials nationwide due to a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection associated with non-sterile medical products.
Plain-English summary
New England Compounding Center, located in Framingham, Massachusetts, is recalling Isovue 200 mg/mL PF and 300 mg/mL PF vials. The recall involves 7,055 vials distributed nationwide. The reason for the recall is a lack of assurance of sterility.
The source text does not specify particular lot codes, stating that all lot codes are affected. No specific dates of distribution or manufacturing are provided in the notice.
Consumers and healthcare providers should stop using the affected vials and contact their supplier or the manufacturer for further instructions on returns or replacements.
The recalled product
- Product
- Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
- Manufacturer
- New England Compounding Center
- Category
- Drug — Injectable Contrast Media
- Affected units
- 7,055
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by New England Compounding Center under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 17 products in this recall →Related recalls
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