Beacon Hill Medical Pharmacy Recalls Potassium Chloride Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Potassium Chloride 2 mEq/mL Injectable because FDA inspectional findings raised concerns about sterility assurance and quality control procedures.
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 medication, which poses a significant risk of infection or serious injury.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling Potassium Chloride 2 mEq/mL Injectable, all presentations, for intravenous and subcutaneous use only. The product was compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, in Southfield, MI.
The recall was initiated due to 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 or specific lot numbers beyond the code 05072013@26.
Healthcare providers and patients should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions. The distribution pattern is listed as USA nationwide.
The recalled product
- Product
- POTASSIUM CHLORIDE 2 MEQ/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 (1)
- 05072013@26
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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