Betamethasone Sodium Phosphate Injection Recalled for Sterility Concerns
New England Compounding Center is recalling Betamethasone Sodium Phosphate injections 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection associated with non-sterile injections.
Plain-English summary
New England Compounding Center is recalling Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, and Betamethasone Sodium Phosphate 12 mg/mL PF Injection. The recall is being conducted because of a lack of assurance of sterility in the products.
The affected products were manufactured by New England Compounding Center in Framingham, MA. The recall covers all lot codes and the products were distributed nationwide.
Consumers and healthcare providers should stop using these products and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA
- Manufacturer
- New England Compounding Center
- Category
- Drug — Injection
- Hazard
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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