Beacon Hill Medical Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Alprostadil 100 mcg/mL injection solution 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 source text explicitly identifies the agency classification as Class II. According to the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable drugs are classified as Severe (Score 4).
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Alprostadil 100 mcg/mL injection solution in all sizes. The product is compounded for intravenous and subcutaneous use only and is sterile, prescription-only medication.
The recall was initiated due to FDA inspectional findings that resulted in concerns associated with quality control procedures impacting sterility assurance. The agency classified this recall as Class II.
The recall covers distribution across the USA nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, 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
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 (1)
- 06262013@33
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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