Beacon Hill Medical Pharmacy Recalls Estriol Oil Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Estriol 5 mg/mL oil injection solution because FDA inspections raised concerns about sterility assurance and quality control.
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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or hospitalization if contaminated.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling all presentations of ESTRIOL 5 MG/ML OIL INJ SOLN. The product is a sterile, prescription-only compounded medication intended for intravenous and subcutaneous use only.
The recall was initiated due to FDA inspectional findings that resulted in concerns associated with quality control procedures impacting sterility assurance. The source text does not specify the number of units affected, specific lot numbers beyond the provided codes, or any reported illnesses or injuries.
Consumers and healthcare providers with this product should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- ESTRIOL 5 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
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 (3)
- 02042013@21
- 02262013@3
- 07242013@38
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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