Agency classClass IIOur severity:Severe FDA (Drugs)·D-0244-2020·Announced 2019-11-13

Red Mountain Compounding Recalls Potassium Chloride Injection Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling specific lots of Potassium Chloride Injection because the FDA identified 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property damage are Severe. While specific injury reports are not detailed in the text, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of harm, aligning with the Severe criteria for Class II recalls involving potential serious health consequences.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Potassium Chloride 2 MEQ/ML Injection Concentrate (PF) 5ml glass vials. The recall is being conducted due to a lack of assurance of sterility in the product.

The affected product is identified by Lot # S07092019DT@08 with an expiration date of 8/9/19. The agency classification for this recall is Class II. The distribution pattern is listed as nationwide in the USA.

Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product: S-POTASSIUM CHLORIDE 2 MEQ/ML INJECTION CONC (PF) 5ml glass vial, Rx Only Red Mountain Compounding Rx.
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable
Hazard: sterility
infection

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 #: S07092019DT@08
Exp 8/9/19

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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