Red Mountain Compounding Recalls S-DMPS Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-DMPS 50mg/ml injection vials because the FDA identified 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which aligns with the rubric criteria for Severe severity.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-DMPS 50MG/ML INJ SOLN (PF), 5 ml glass vials. The recall was initiated because the U.S. Food and Drug Administration identified a lack of assurance of sterility for the product.
The affected product is a prescription-only injectable solution. The specific lot number is S05092019DH@06, with an expiration date of 8/9/19. The product was distributed nationwide in the United States.
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-DMPS 50MG/ML INJ SOLN (PF), 5 ml glass vial, Rx Only, Red Mountain Compounding RX.
- Category
- Drug — Injectable 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 (2)
- Lot #: S05092019DH@06
- Exp 8/9/19
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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