Red Mountain Compounding Recalls S-Atropine Ophthalmic Solution for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Atropine 0.02% ophthalmic solution due to a lack of assurance of sterility. The affected product is a prescription eye drop distributed nationwide.
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: The recall involves a risk-of-harm product (sterility failure in an ophthalmic solution) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Atropine 0.02% Ophthalmic Solution, 10 ml dropper bottles. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is a prescription-only medication. The specific lots involved are S05232019DH@03 (expiration date 8/23/19) and S07172019DT@03 (expiration date 10/17/19). The product was distributed nationwide in the United States.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- S-ATROPINE 0.02% OPTHALMIC SOLUTION, 10 ML dropper bottle, RX only, Red Mountain Compounding RX
- Category
- Drug — Ophthalmic Solution
- 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 (4)
- Lot #: S05232019DH@03
- Exp 8/23/19
- S07172019DT@03
- Exp 10/17/19
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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