Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0029-2022·Announced 2021-11-03

Magnesium Chloride Injection Recalled for Sterility Assurance Concerns

Red Mountain Compounding Pharmacy is recalling Magnesium Chloride 200 mg/mL injection because FDA inspection raised concerns about lack of assurance of sterility. The product was distributed to approximately 494 patients in seven states.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The source states FDA inspection raised sterility assurance concerns but does not report any actual illnesses, injuries, or confirmed contamination. This is an FDA Class II recall with no reported adverse events, placing it in the moderate category under the rubric criteria for precautionary recalls without confirmed harm.

Plain-English summary

Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling Magnesium Chloride 200 mg/mL multiple-dose vial (MDV) injection for prescription use. The recall was initiated because FDA inspection raised sterility assurance concerns about the product.

Approximately 494 patients and consumers who received prescriptions for this product are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. The recalled product encompasses all lots within their expiry dates.

Patients who have received this product should contact their healthcare provider or pharmacy for guidance. The FDA classified this as a Class II recall.

The recalled product

Product: Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable Compounded Medication
Hazard: sterility-assurance
injectable-drug

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 (1)

all lots within expiry

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 40 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 40 products in this recall →

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

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