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.
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 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.
See all 86 products in this recall →Related recalls
Same manufacturer · Beacon Hill Medical Pharmacy, P.C.
See all →- SevereBeacon Hill Medical Pharmacy Recalls B-12 Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
- HighBeacon Hill Medical Pharmacy Recalls Sermorelin Acetate Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
- SevereBeacon Hill Medical Pharmacy Recalls Potassium Chloride Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
- SevereBeacon Hill Medical Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
- SevereBeacon Hill Medical Pharmacy Recalls Multitrace-5 Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereL-Arginine Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereWells Pharmacy Recalls Arginine HCl Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- SevereL-Arginine Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2015-09-23
- SevereAxia Pharmaceutical Recalls Arginine Hydrochloride Injection Due to Sterility Concerns
FDA (Drugs) · 2020-03-11
- HighBuprenorphine Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2023-02-01
- SevereOlympia Pharmacy Recalls L-Arginine Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17