US Compounding Recalls Betamethasone Vials Due to Sterility Concerns
US Compounding Inc is recalling 6,008 vials of Betamethasone SP PF due to deficient practices that may impact sterility assurance.
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 risk of serious injury (infection) due to lack of sterility assurance, which aligns with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
US Compounding Inc is recalling 6,008 vials of Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and was distributed nationwide.
The recall is being conducted because of deficient practices which may have an impact on sterility assurance. The firm is recalling all sterile preparations that are within expiry due to these concerns.
Affected lot numbers include 20150107@27, 20150704@5, and 20152005@22. Consumers and healthcare providers should stop using the product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3016-02
- Manufacturer
- US Compounding Inc
- Category
- Drug — Sterile Injectable
- Affected units
- 6,008
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 (3)
- Lot Numbers: 20150107@27 BUD:12/28/2015
- 20150704@5 BUD: 10/4/2015
- 20152005@22 BUD: 11/16/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding Inc 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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