US Compounding Recalls Betamethasone SP Vials Due to Sterility Concerns
US Compounding Inc is recalling Betamethasone SP vials nationwide because deficient practices may have impacted sterility assurance.
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 involves a lack of sterility assurance in injectable products, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
US Compounding Inc is recalling 100 vials of Betamethasone SP, 2 mL (6 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is distributed nationwide. The recall includes specific lot numbers 20150806@9 and 20152107@38.
The recall is being conducted due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry dates. This is an FDA Class II recall.
Healthcare providers and patients should stop using the affected vials and contact the recalling firm for instructions on return or disposal. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3240-07
- Manufacturer
- US Compounding Inc
- Category
- Drug — Sterile Injectable
- Affected units
- 100
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 (2)
- Lot Numbers: 20150806@9 BUD: 12/5/2015
- 20152107@38 BUD: 1/17/2016
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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