Agency classClass IIOur severity:Severe FDA (Drugs)·D-0274-2020·Announced 2019-11-13

Red Mountain Compounding Pharmacy Recalls S-MIC/B12/Carnitine Injection for Sterility Concerns

Red Mountain Compounding Pharmacy is recalling specific lots of S-MIC/B12(C)/Carnitine injection due to a lack of assurance of sterility. The product was distributed nationwide in the USA.

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 agency classification as Class II. According to the rubric, an FDA Class II recall involving a risk-of-harm product (sterility failure in an injectable drug) where injury has not yet been reported is classified as Severe (Score 4).

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling specific lots of S-MIC/B12(C)/Carnitine 25/50/50/1/50mg/ml MDV Injection. The recall is being conducted because of a lack of assurance of sterility in the affected products.

The affected lots were distributed nationwide in the USA. The source text lists multiple lot numbers and expiration dates, including S07172019DT@10, S02142019DH@01, and S03192019DT@04, among others.

Consumers and healthcare providers should stop using the affected lots and contact the recalling firm for further instructions or a replacement. The FDA classifies this recall as Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S07172019DT@10, Exp 1/17/20; S02142019DH@01, Exp 8/14/19; S03192019DT@04,Exp 9/19/19; " S04162019DT@15, Exp 10/16/19; S07232019DH@04, Exp 1/23/20; S02142019DH@01, Exp 8/14/19; S04162019DT@15, Exp 9/9/19…
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — 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 (6)

Lot #: S07022019DT@09
Exp 10/2/19
S05082019DT@08
Exp 8/8/19
S06042019DT@07
Exp 9/4/19

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.

See all 100 products in this recall →

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

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