The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1006-2013·Announced 2013-09-18

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.

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. 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
Hazard

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.

See all 86 products in this recall →

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