Red Mountain Compounding Recalls Benzalkonium Chloride Solution Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling benzalkonium chloride solution because the product lacks assurance of sterility.
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 a medical product, which meets the criteria for a Severe rating.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic containers. The recall is being conducted because the product lacks assurance of sterility.
The affected product is a prescription-only medication intended for irrigation use. The recall involves four 1000ml plastic containers distributed nationwide in the USA. Specific lot numbers and expiration dates are listed in the recall documentation.
Consumers with this product should stop using it and contact their healthcare provider or the recalling pharmacy for instructions on how to proceed.
The recalled product
- Product
- S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, Rx only, Red Mountain Compounding Rx.
- Hazard
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 (8)
- Lot #: S03142019DT@09
- Exp 9/14/19
- S05052019DH@04
- Exp 11/5/19
- S06192019DT@03
- Exp 12/19/19
- S06262019DT@12
- Exp 12/26/19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy 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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