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.
What this means for you
Illness, injury, or structural failure has been reported. 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:
- AZ
- CA
- FL
- MN
- MT
- TX
- UT
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