Red Mountain Compounding Recalls S-Sodium Selenite Injections Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Sodium Selenite 0.219% injections because the agency could not ensure the product was sterile.
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 3/5 (High).
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: The recall involves a risk-of-harm product (injection) where injury has not yet been reported, and the agency classification is Class II.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Sodium Selenite 0.219% Injections. The recall involves 11 10 ml glass vials of the prescription-only medication. The product was distributed nationwide in the United States.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify the exact cause of the sterility failure or report any specific illnesses or injuries associated with the product.
Consumers who have this product should contact their healthcare provider or the recalling pharmacy for instructions on how to dispose of the medication or obtain a replacement. The affected lot numbers are S03062019JL@11, S04282019DH@05, S06182019DT@04, S06242019DH@11, and S07232019DH@15.
The recalled product
- Product
- S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compounding Rx
- Category
- Drug — Injectable
- 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 (10)
- Lot #: S03062019JL@11
- Exp 9/6/19
- S04282019DH@05
- Exp 10/28/19
- S06182019DT@04
- Exp 12/18/19
- S06242019DH@11
- Exp 12/24/19
- " S07232019DH@15
- Exp 1/23/20
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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