Benzalkonium Chloride Solution Recalled Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling Benzalkonium Chloride 0.013% Solution due to lack of assurance of sterility identified during an FDA inspection. Approximately 494 patients in seven states received prescriptions for this product.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterile injectable or ophthalmic product with unassured sterility, which presents a risk of serious infection if contaminated. Although no illnesses or injuries are reported in the source text, the hazard (contamination/infection from lack of sterility assurance in a product intended for sensitive use) is of sufficient risk to warrant High severity under the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Red Mountain Compounding Pharmacy (First Royal Care Co. LLC) is recalling all lots of Benzalkonium Chloride 0.013% Solution (prescription only) due to a lack of assurance of sterility. The recall was initiated after an FDA inspection raised concerns about the sterility assurance of this product.
Approximately 494 patients and consumers who received prescriptions for this product are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah.
Consumers who have received prescriptions for this product should contact their healthcare provider or pharmacy for guidance. The product is prescription-only and should not be used without medical supervision.
The recalled product
- Product
- BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Category
- Drug — Compounded Pharmaceutical
- Hazard
- sterility-assurance
- contamination-risk
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)
- all lots within expiry
Distribution
Distributed in 7 states:
- AZ
- CA
- FL
- MN
- MT
- TX
- UT
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