US Compounding Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns
US Compounding Inc is recalling 13,843 vials of Triamcinolone diacetate USP (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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
US Compounding Inc is recalling 13,843 vials of Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and was 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 affected lots have expiration dates ranging from September 2015 to January 2016.
Patients who have received this medication should contact their healthcare provider for guidance. The recall covers specific lot numbers listed in the official FDA notice, including lots 20150204@7, 20150304@1, and others with corresponding best-use dates.
The recalled product
- Product
- Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3205-06
- Manufacturer
- US Compounding Inc
- Category
- Drug — Sterile Injectable
- Affected units
- 13,843
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 (15)
- Lot: 20150204@7 BUD: 9/29/2015
- 20150304@1 BUD: 9/29/2015
- 20150604@23 BUD: 10/3/2015
- 20150807@50 BUD: 1/4/2016
- 20150906@23 BUD: 12/6/2015
- 20150906@24 BUD: 12/6/2015
- 20152005@42 BUD: 11/16/2015
- 20152206@52 BUD: 12/19/2015
- 20152406@14 BUD: 12/21/2015
- 20152603@26 BUD: 9/22/2015
- 20152804@20 BUD: 10/25/2015
- 20152904@20 BUD: 10/26/2015
- 20152907@8 BUD: 1/25/2016
- 20151603@56 BUD: 9/12/2015
- 20152406@30 BUD: 12/21/2015
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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