Beacon Hill Medical Pharmacy Recalls Triple-Testosterone Injections Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Triple-Testosterone oil injection solutions because FDA inspections raised concerns about 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable drugs are categorized as Severe.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Triple-Testosterone 250 mg/mL and 200 mg/mL oil injection solutions. The recall covers all configurations of these sterile, prescription-only products intended for intravenous and subcutaneous use only.
The recall was initiated following FDA inspectional findings that identified concerns associated with quality control procedures. These findings resulted in a lack of assurance regarding the sterility of the compounded products.
The affected products were distributed nationwide in the United States. Patients who have received these injections should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML OIL INJ SOLN, 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 (8)
- 07182013@1
- 03202013@19
- 01022013@31
- 01292013@2
- 04182013@10
- 06142013@1
- 07122013@1
- 07132013@9
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 →Related recalls
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