Agency classClass IIOur severity:Severe FDA (Drugs)·D-0241-2020·Announced 2019-11-13

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.

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 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.
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Compounded Injectable
Hazard: lack-of-sterility

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.

See all 100 products in this recall →

Same manufacturer · First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

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