Red Mountain Compounding Recalls S-B5/B6/B12M Solution Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-B5/B6/B12M solution vials because the FDA cannot ensure the product is 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in a medical product, which meets the rubric criteria for a Severe rating due to the potential for significant health consequences.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vials. The recall is being conducted because the U.S. Food and Drug Administration (FDA) has determined there is a lack of assurance of sterility for the product.
The affected product is prescription-only and was distributed nationwide in the USA. The recall includes specific lots with expiration dates ranging from August 2019 to October 2019. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the product. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, Red Mountain Compounding RX.
- Category
- Drug — Compounded Injectable
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 #: S05132019DH@02
- Exp 8/13/19
- S05142019DT@05
- Exp 8/14/19
- S07032019DT@10
- Exp 10/3/19
- S07182019DH@01
- Exp 10/18/19
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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