Red Mountain Compounding Recalls S-Lysine HCL Vials Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Lysine HCL 100mg/mL vials because the FDA cannot ensure the product is sterile.
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 source text identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are mapped to a score of 4 (Severe), particularly when involving potential hospitalization or significant injury risks associated with sterility failures.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Lysine HCL 100mg/mL MDV, 30mL vials. The recall is being conducted because the U.S. Food and Drug Administration (FDA) cannot assure the sterility of the product.
The affected product is identified by Lot # S07292019DH@06 with an expiration date of 8/12/19. The recall is classified as FDA Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers who have this specific lot of S-Lysine HCL should stop using it and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- S-LYSINE HCL 100MG/ML MDV, 30ML vial, Red Mountain Compounding Rx
- Category
- Drug — Compounded Medication
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 #: S07292019DH@06
- Exp 8/12/19
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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