Beacon Hill Medical Pharmacy Recalls Triamcinolone Acetonide Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling compounded Triamcinolone Acetonide injections because FDA inspections raised concerns about 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. According to the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable drugs are categorized as Severe (Score 4), particularly when the hazard involves potential serious injury or infection, even if specific hospitalization reports are not detailed in this snippet.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling all configurations of compounded Triamcinolone Acetonide 80 mg/mL injection suspension. The product is intended for intravenous and subcutaneous use only and is sterile, prescription-only medication.
The recall was initiated following FDA inspectional findings that identified concerns regarding quality control procedures which impacted the assurance of sterility. The source text does not specify the number of units affected, specific lot numbers, or the geographic distribution of the product.
Patients who have received this medication should contact their healthcare provider for guidance. The source text does not provide specific instructions for consumers or reports of adverse health events.
The recalled product
- Product
- TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Manufacturer
- Beacon Hill Medical Pharmacy, P.C.
- Category
- Drug — Compounded Injectable
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 (5)
- 03252013@20
- 04152013@11
- 05232013@25
- 06052013@32
- 07022013@24
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. 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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