US Compounding Recalls Triamcinolone Acetonide Vials Due to Sterility Concerns
US Compounding Inc is recalling 1,244 vials of compounded Triamcinolone acetonide 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 a sterile injectable product, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.
Plain-English summary
US Compounding Inc is recalling 1,244 vials of Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is distributed nationwide. The recall includes specific lot codes with expiration dates ranging from November 2, 2015, to January 2, 2016.
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. This is an FDA Class II recall, indicating a situation that might cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected vials immediately. Consumers should check their medication for the specific NDC 62295-3203-07 and the listed lot codes to determine if they are affected. If the product is found, it should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3203-07
- Manufacturer
- US Compounding Inc
- Category
- Drug — Sterile Injectable
- Affected units
- 1,244
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 (3)
- Lot Code: 20150605@28 BUD: 11/2/2015
- 20150607@38 BUD: 1/2/2016
- 20150906@3 BUD: 12/6/2015
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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