US Compounding Recalls Omnipaque 300 Vials Due to Sterility Concerns
US Compounding Inc is recalling 8,218 vials of Omnipaque 300 injection 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
US Compounding Inc is voluntarily recalling 8,218 vials of Omnipaque 300 (600 mg/2 mL), a prescription-only injectable medication. The product is distributed nationwide and is compounded by US Compounding Pharmacy in Conway, Arkansas.
The recall is being conducted because of deficient practices that may have an impact on the assurance of sterility for these preparations. The affected lots have expiration dates ranging from September 12, 2015, to December 26, 2015.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3137-02
- Manufacturer
- US Compounding Inc
- Category
- Drug — Injectable
- Affected units
- 8,218
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 (11)
- Lot Code: 20150604@4 BUD: 10/3/2015
- 20152205@1 BUD: 11/18/2015
- 20152303@3 BUD: 9/19/2015
- 20150604@1 BUD: 10/3/2015
- 20151304@27 BUD: 9/19/2015
- 20151506@19 BUD: 12/12/2015
- 20151506@27R BUD: 11/28/2015
- 20151603@2 BUD: 9/12/2015
- 20152004@13 BUD: 10/17/2015
- 20152206@13 BUD: 12/19/2015
- 20152906@7 BUD: 12/26/2015
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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