FDA Recalls Compounded Injectable Solution Due to Sterility Assurance Concerns
Beacon Hill Medical Pharmacy is recalling compounded glutathione/methyl/lido injectable solutions because FDA inspections 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 recall is classified as FDA Class II and involves a lack of sterility assurance in an injectable product, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for GLUTATHIONE/METHYL/LIDO 100/25/20 MG/ML INJ SOLN and GLUTATHIONE/METHYL/LIDO 100/25/20MG/ML (PF) INJ SOLN. The product is compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, in Southfield, Michigan, and is intended for intravenous and subcutaneous use only.
The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. The recall covers all presentations of the product.
Healthcare providers and patients who have received or possess this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The product is distributed nationwide in the United States.
The recalled product
- Product
- GLUTATHIONE/METHYL/LIDO 100/25/20 MG/ML INJ SOLN and GLUTATHIONE/METHYL/LIDO 100/25/20MG/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 (1)
- 06132013@6 04242013@33
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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