New England Compounding Center Recalls Betamethasone Repository Injections
New England Compounding Center is recalling Betamethasone Repository injections due to a lack of assurance of sterility. The recall covers all lot codes distributed nationwide.
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, which poses a risk of serious health consequences such as infection, meeting the criteria for a Severe rating.
Plain-English summary
New England Compounding Center, located in Framingham, MA, is recalling Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection. The recall is being conducted because of a lack of assurance of sterility in the product.
The recall applies to all lot codes of these injections. The products were distributed nationwide. The U.S. Food and Drug Administration has classified this recall as Class II.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA
- Manufacturer
- New England Compounding Center
- Category
- Drug — Injectable Steroid
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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