Beacon Hill Medical Pharmacy Recalls Estradiol Cypionate Injections for Sterility Concerns
Beacon Hill Medical Pharmacy is recalling compounded estradiol cypionate injections due to FDA inspectional findings regarding quality control and sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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, an FDA Class II recall involving a sterile medical product where sterility assurance is compromised is assigned a score of 4 (Severe) due to the potential for serious adverse health consequences, even without reported hospitalizations in the text.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions, is recalling Estradiol Cypionate 5, 10, and 40 mg/mL oil injection solutions. The affected products are compounded sterile solutions intended for intravenous and subcutaneous use only. The recall covers all configurations of the product distributed nationwide in the United States.
The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures. Specifically, the inspection identified issues that impacted the assurance of sterility for the compounded medications. The source text does not report any specific illnesses, injuries, or deaths associated with the use of these products.
Patients who have received these injections should contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ESTRADIOL CYPIONATE 5, 10, 40 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.
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)
- 02072013@11
- 04042013@14
- 01312013@3
- 01072013@8
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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