Red Mountain Compounding Pharmacy Recalls S-DMSO 100% Sterile Solution
Red Mountain Compounding Pharmacy is recalling S-DMSO 100% sterile solution vials due to a lack of assurance of sterility.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 for significant injury or property damage reports or high-risk conditions.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-DMSO 100% (PF) STERILE SOLUTION. The product is packaged in 50 ml and 10 ml glass vials and is available by prescription only. The recall is being conducted because of a lack of assurance of sterility.
The affected lots include specific 50 ml and 10 ml vials with expiration dates ranging from October 2019 to December 2019. The recall is distributed nationwide in the USA.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- S-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 10 ml glass vials, Rx Only, Red Mountain Compounding Rx
- Category
- Drug — Sterile 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 (13)
- Lot #:a) S04242019DT@15
- Exp 10/24/19
- S05012019DH@03
- Exp 11/1/19
- S05072019DT@10
- Exp 11/7/19
- S05072019DT@12
- S06202019DT@03
- Exp 12/20/19
- S06202019DT@04
- S07222019DH@05
- Exp 07/22/2019 b) S06272019DT@06
- Exp 12/27/19
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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