US Compounding Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns
US Compounding Inc is recalling 33,778 vials of Triamcinolone diacetate USP PF (40 mg/mL) nationwide 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe; while no specific injuries are reported in the text, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of harm (sepsis/infection) that aligns with the Severe tier for high-risk medical products where sterility is compromised.
Plain-English summary
US Compounding Inc is recalling 33,778 vials of Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is distributed nationwide.
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. The FDA has classified this as a Class II recall.
Patients who have received this medication should contact their healthcare provider for guidance. The specific lot codes and best-use dates for the affected vials are listed in the official recall documentation.
The recalled product
- Product
- Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01
- Manufacturer
- US Compounding Inc
- Affected units
- 33,778
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 (13)
- Lot Code: 20150608@19 BUD: 2/2/2016
- 20150807@35 BUD: 1/4/2016
- 20152104@12 BUD: 10/1//2015
- 20150105@2 BUD: 10/28/2015
- 20150605@36 BUD: 11/2/2015
- 20150607@26 BUD: 1/2/2016
- 20150904@32 BUD: 10/6/2015
- 20150906@35 BUD: 12/6/2015
- 20151506@45 BUD: 12/12/2015
- 20151603@43 BUD: 9/12/2015
- 20152204@15 BUD: 10/19/2015
- 20152506@35 BUD: 12/22/2015
- 20152907@1 BUD: 1/25/2016
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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