Beacon Hill Medical Pharmacy Recalls Testosterone Cypionate Injections for Sterility Concerns
Beacon Hill Medical Pharmacy is recalling compounded testosterone cypionate injections due to FDA inspectional findings regarding sterility assurance and quality control.
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 defect is structural to the product's safety profile (sterility).
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling compounded Testosterone Cypionate 100 mg/mL, 200 mg/mL, and 20 mg/mL oil injection solutions. The recall covers all configurations of the sterile, prescription-only product intended for intravenous and subcutaneous use.
The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures impacting the assurance of sterility. The source text does not specify the number of affected units, specific lot numbers beyond the provided codes, or any reported illnesses or injuries associated with the product.
Patients who have received these compounded injections should contact their healthcare provider for guidance. The source text does not provide specific consumer instructions beyond the general context of a drug recall.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all configuration, 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 (4)
- 07222013@15
- 04192013@5
- 06272013@26
- 07012013@5
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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