Beacon Hill Medical Pharmacy Recalls Hyaluronidase Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Hyaluronidase 150 U/ML and 200 U/ML Injectable due to FDA inspectional findings regarding 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 recall is classified as FDA Class II and involves a sterile injectable medication where sterility assurance is compromised, posing a risk of serious injury or death from infection, which aligns with the 'Severe' criteria for significant injury reports or high-risk structural/quality defects in medical products.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Hyaluronidase 150 U/ML and 200 U/ML Injectable. The product is available in all presentations for intravenous and subcutaneous use only and is sterile, prescription-only medication.
The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures. These findings specifically impacted the assurance of sterility for the compounded product. The agency has classified this recall as Class II.
The recall covers products distributed nationwide in the United States. Patients and healthcare providers should stop using the affected Hyaluronidase Injectable and contact their pharmacist or healthcare provider for further instructions or replacement.
The recalled product
- Product
- HYALURONIDASE 150 U/ML and 200 U/ML INJECTABLE, 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)
- 05312013@24
- 04242013@34
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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