Beacon Hill Medical Pharmacy Recalls Parabens Water for Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling all presentations of Parabens Water for Injection because FDA inspectional findings raised concerns about quality control procedures impacting 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, and the hazard involves a lack of assurance of sterility in a product intended for intravenous and subcutaneous use, which poses a significant risk of serious injury.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling all presentations of Parabens Water for Injection. The product is sterile, prescription-only, and intended for intravenous and subcutaneous use only.
The recall was initiated following FDA inspectional findings that resulted in concerns associated with quality control procedures. These findings specifically impacted the assurance of sterility for the compounded product.
The recall covers the product distributed nationwide in the United States. Specific lot codes identified in the recall notice include 04012013@21 and 07252013@15. Patients and healthcare providers should stop using the recalled product and contact their pharmacist or physician for guidance on alternative treatments or replacements.
The recalled product
- Product
- PARABEN WATER FOR INJECTION, 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 (2)
- 04012013@21
- 07252013@15
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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