Beacon Hill Medical Pharmacy Recalls Glutathione Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Glutathione 200 mg/mL injection solution because FDA inspections raised concerns about sterility assurance and quality control.
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 an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling all presentations of Glutathione 200 mg/mL (PF) Injection Solution. The product is a sterile, prescription-only compounded medication intended for intravenous and subcutaneous use only.
The recall was initiated following FDA inspectional findings that resulted in concerns associated with quality control procedures impacting sterility assurance. The source text does not specify the number of units affected, specific lot numbers, or the exact distribution dates, though the product was distributed nationwide in the United States.
Consumers and healthcare providers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- GLUTATHIONE 200 MG/ML (PF) 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 (6)
- 03192013@30
- 02202013@6
- 04042013@2
- 04302013@20
- 04252013@19 06202013@35
- 06212013@17
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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