New England Compounding Center Recalls Dexamethasone Sodium Phosphate Vials
New England Compounding Center is recalling Dexamethasone Sodium Phosphate vials due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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 the hazard involves a lack of assurance of sterility in a drug product, which carries a risk of serious injury or death.
Plain-English summary
New England Compounding Center is recalling Dexamethasone Sodium Phosphate 4 mg/mL, 6 mg/mL, and 8 mg/mL vials. The recall is being conducted because of a lack of assurance of sterility.
The affected products were distributed nationwide. The recall includes all lot codes for these specific vials.
Consumers and healthcare providers should stop using the recalled vials and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA
- Manufacturer
- New England Compounding Center
- Category
- Drug — Injectable Sterile Drug
- Hazard
- Affected units
- 20
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.
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