Beacon Hill Medical Pharmacy Recalls Arginine Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Arginine (R-Gene) 100 mg/mL injectable because FDA inspectional findings raised concerns about 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling all presentations of Arginine (R-Gene) 100 mg/mL injectable. The product is compounded for intravenous and subcutaneous use only and is sterile, prescription-only medication.
The recall was initiated because FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. The source text does not specify the number of units affected or the specific dates of distribution.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- ARGININE (R-GENE) 100 MG/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 — 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 (4)
- 03262013@3
- 04302013@21
- 06132013@1
- 07102013@22
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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