US Compounding Recalls Tri-Mix Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 797 vials of Tri-Mix 30/1/10 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 recall is classified as FDA Class II and involves a sterile injectable medication where deficient practices may impact sterility assurance, posing a risk of serious injury or death from infection.
Plain-English summary
US Compounding Inc is recalling 797 vials of Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is distributed 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 agency has classified this recall as Class II.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal. Specific lot codes and best-use dates are listed in the official recall notice.
The recalled product
- Product
- Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3256-05
- Manufacturer
- US Compounding Inc
- Affected units
- 797
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 (8)
- Lot Code: 20151305@17 BUD: 9/16/2015
- 20151504@18 BUD: 9/16/2015
- 20151903@13 BUD: 9/12/2015
- 20152107@3 BUD: 1/16/2016
- 20152204@6 BUD: 9/16/2015
- 20152403@13 BUD: 9/12/2015
- 20152403@21 BUD: 9/16/2015
- 20152904@8 BUD: 9/16/2015
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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