Red Mountain Compounding Recalls S-Atropine 0.5% Ophthalmic Solution
Red Mountain Compounding Pharmacy is recalling S-Atropine 0.5% ophthalmic solution due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score according to the rubric, particularly given the risk of infection from non-sterile ophthalmic products.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Atropine 0.5% ophthalmic solution, 10 ml dropper bottles. The recall is due to a lack of assurance of sterility in the product.
The affected product is prescription-only and was distributed nationwide in the USA. The specific lot number is S05232019DH@04, with an expiration date of 8/23/19.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compounding RX.
- Category
- Drug — Ophthalmic
- 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 (2)
- Lot #: S05232019DH@04
- Exp 8/23/19
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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