Red Mountain Compounding Pharmacy Recalls S-MIC Solution Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-MIC 25/50/50MG/ML MDV SOLN vials nationwide due to 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile medical products.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-MIC 25/50/50MG/ML MDV SOLN, 30ml glass vials. The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product is prescription-only and was distributed nationwide in the USA. The recall involves 24 vials of 30 ml each. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between August 2019 and January 2020.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- S-MIC 25/50/50MG/ML MDV SOLN, 30ml glass vial, Rx Only, Red Mountain Compounding RX.
- Category
- Drug — Compounded Injectable
- 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 (12)
- Lot #: S02142019DH@01
- Exp 8/14/19
- S03112019DT@04
- Exp 09/11/2019
- S03192019DT@04
- Exp 9/19/19
- S04162019DT@15
- Exp 10/16/19
- S07172019DT@10
- Exp 1/17/20
- S07232019DH@04
- Exp 1/23/20
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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