Red Mountain Compounding Recalls S-DMSO Eye Drops Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of S-DMSO 6.25% ophthalmic solution because the product lacks 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 under the rubric, particularly given the risk of infection associated with non-sterile ophthalmic products.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-DMSO 6.25% OPTH SOLN, 10 ml dropper bottles. The recall involves seven 10 ml dropper bottles distributed nationwide in the USA. The specific lots affected are S05082019ST@05, S05212019DT@08, S05312019DT@10, S06272019DT@03, and S07222019DH@06, with expiration dates ranging from August 8, 2019, to October 22, 2019.
The recall is being conducted because the product lacks assurance of sterility. This is a prescription-only medication intended for ophthalmic use.
Consumers who have these specific lots of the product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return the product.
The recalled product
- Product
- S-DMSO 6.25% OPTH SOLN, 10 ml dropper bottle, Rx Only, Red Mountain Compounding Rx
- Category
- Drug — Ophthalmic Solution
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 #:S05082019ST@05
- Exp 8/8/19
- S05212019DT@08
- Exp 8/21/19
- S05312019DT@10
- Exp 8/31/19
- S06272019DT@03
- Exp 9/27/19
- S07222019DH@06
- Exp 10/22/19
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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