Beacon Hill Medical Pharmacy Recalls Compounded Injectable Solution Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling compounded B12/E2/E3/PROG/TEST injectable solution due to FDA inspectional findings regarding 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 and involves a lack of sterility assurance in an injectable solution, which poses a significant risk of serious injury or death from infection.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling all presentations of B12/E2/E3/PROG/TEST 1/3.75/2.5/50/45 MG/ML OIL INJ SOLN. The product is a sterile, prescription-only compounded solution intended for intravenous and subcutaneous use only.
The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings identified concerns associated with quality control procedures that impacted sterility assurance for the product.
The recall is distributed nationwide in the USA. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- B12/E2/E3/PROG/TEST 1/3.75/2.5/50/45 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 (1)
- 03202013@31
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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