FDAClass IINovember 3, 2021

Magnesium Chloride recall: Sterility Concern

Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

Why was Magnesium Chloride recalled?

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

all lots within expiry

Product
Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Recalling firm
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Quantity
N/A
Distribution
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
Recall date
November 3, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls