The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-952-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Dual-Testosterone Injections for Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Dual-Testosterone oil injection solutions due to FDA inspectional findings regarding quality control and 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. Per the rubric, FDA Class II recalls involving significant safety concerns such as sterility assurance failures in injectable drugs are categorized as Severe (Score 4), as they carry a reasonable probability of adverse health consequences.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions, is recalling all presentations of Dual-Testosterone 20, 50, 100, 150, and 200 mg/mL oil injection solutions. The product is compounded for intravenous and subcutaneous use only and is sterile, prescription-only medication.

The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures. Specifically, the findings impacted the assurance of sterility for the compounded products. The recall covers products distributed nationwide in the United States.

Patients who have received or possess this medication should contact their healthcare provider or pharmacist for guidance on next steps. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
DUAL-TESTOSTERONE 20, 50, 100, 150, 200 MG/ML OIL INJ SOLN, all presentations, 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 (20)

  • 05302013@6
  • 02112013@5
  • 04192013@21
  • 05032013@14
  • 01252013@11
  • 03272013@17
  • 01252013@8
  • 03272013@22
  • 01312013@9
  • 06062013@24
  • 01032013@1
  • 01152013@14
  • 01292013@4
  • 01312013@10
  • 02142013@9
  • 03062013@10
  • 03112013@6
  • 03112013@4
  • 04042013@16
  • 04122013@18

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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Same manufacturer · Beacon Hill Medical Pharmacy, P.C.

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