US Compounding Recalls Vitamin D3 Vials Due to Sterility Concerns
US Compounding Inc is recalling 55 vials of Vitamin D3 in Olive Oil due to deficient practices that may impact 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 an injectable medication, which poses a significant risk of serious injury or death from infection, fitting the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
US Compounding Inc is recalling 55 vials of Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vials. The product is compounded for intramuscular use only and is available by prescription. The recall is nationwide.
The recall was initiated 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. The specific lot code is 20151703@26 with a best-use date of 9/13/2015.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The product is distributed nationwide.
The recalled product
- Product
- Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06
- Manufacturer
- US Compounding Inc
- Affected units
- 55
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 Code: 20151703@26 BUD: 9/13/2015
- 20151703@26 BUD: 9/13/2015
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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