Agency classClass IIOur severity:Severe FDA (Drugs)·D-0028-2022·Announced 2021-11-03

Calcium Chloride Injection Recalled Due to Sterility Assurance Concerns

Red Mountain Compounding Pharmacy is recalling Calcium Chloride 100 mg/mL multi-dose vial injection due to lack of assurance of sterility identified during FDA inspection. The product was distributed to approximately 494 patients across 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 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: This is an FDA Class II recall involving a sterile injectable product with confirmed sterility assurance deficiencies identified by FDA inspection. Lack of sterility assurance in injectables carries significant risk of serious infection or harm, placing this at the Severe threshold even without reported illnesses.

Plain-English summary

Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling Calcium Chloride 100 mg/mL multi-dose vial injection (MDV INJ) for intravenous use. The recall was initiated because FDA inspection raised concerns regarding the assurance of sterility in the product's manufacturing process.

The affected product was distributed to approximately 494 patients and consumers with valid prescriptions across Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots currently within their expiration dates are included in this recall.

Patients who have received this product should contact their healthcare provider immediately to discuss the recall and determine appropriate next steps. Healthcare providers and pharmacies that dispensed this product should cease distribution and contact their patients about the recall.

The recalled product

Product: Calcium Chloride, 100 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
Hazard: sterility-defect
contamination-risk

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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