Beacon Hill Medical Pharmacy Recalls Estradiol Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Estradiol Cypionate/Progesterone/Testosterone Cypionate injections due to FDA inspectional findings regarding 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 quality control failures like sterility assurance in injectable drugs are categorized as Severe (Score 4), particularly given the risk of infection from non-sterile injections.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Estradiol Cypionate/Progesterone/Testosterone Cypionate 0.5/10/10 mg/mL oil injection solution. The recall covers all presentations 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 units affected or the specific distribution locations beyond the nationwide pattern indicated in the metadata.
Consumers and healthcare providers should discontinue use of the recalled product and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with the use of this product.
The recalled product
- Product
- ESTRADIOL CYP/PROG/TEST CYP 0.5/10/10 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 — Injectable Steroids
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 (2)
- 05012013@25
- 06202013@6
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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