New England Compounding Center Recalls Clonidine Vials Due to Sterility Concerns
New England Compounding Center is recalling Clonidine 100 mcg/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 and involves a lack of assurance of sterility in a drug product, which poses a significant risk of infection or serious injury.
Plain-English summary
New England Compounding Center is recalling Clonidine 100 mcg/mL PF, 1mL and 2 mL vials. The recall involves 2,747 vials distributed nationwide. The reason for the recall is a lack of assurance of sterility.
The affected product was manufactured by New England Compounding Center in Framingham, MA. All lot codes are included in this recall.
Consumers and healthcare providers should stop using the recalled vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA
- Manufacturer
- New England Compounding Center
- Category
- Drug — Injectable Medication
- Affected units
- 2,747
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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