Red Mountain Compounding Recalls S-Atropine Ophthalmic Solution Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of S-Atropine 0.01% Ophthalmic Solution because the agency could not ensure the product was sterile.
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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant health consequences (such as sterility issues in ophthalmic products) are classified as Severe.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling specific lots of S-Atropine 0.01% Ophthalmic Solution. The product is packaged in 10 ml and 50 ml dropper bottles and is available by prescription only. The recall was initiated due to a lack of assurance of sterility.
The affected products were distributed nationwide in the USA. The specific lot numbers involved are S06112019DH@22 (Exp 9/11/19), S06202019DT@10 (Exp 9/20/19), S07312019DH@07 (Exp 10/31/19), and S07302019DH@07 (Exp 10/30/19). The quantity recalled includes six 10 ml bottles and one 50 ml dropper bottle.
Consumers who have these specific products should stop using them and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 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 (8)
- Lot #: a) S06112019DH@22
- Exp 9/11/19
- S06202019DT@10
- Exp 9/20/19
- S07312019DH@07
- Exp 10/31/19
- b) S07302019DH@07
- Exp 10/30/19
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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