Agency classClass IIOur severity:Severe FDA (Drugs)·D-0286-2016·Announced 2015-11-25

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard: sterility
infection
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.

See all 59 products in this recall →

Same manufacturer · US Compounding Inc

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Same hazard · sterility