Calcium Gluconate 10% Injectable Recalled for Sterility Assurance
Red Mountain Compounding Pharmacy is recalling Calcium Gluconate 10% Injectable (PF) due to lack of assurance of sterility following an FDA inspection. The product was distributed to approximately 494 patients across seven states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable medication. Lack of sterility assurance in injectables poses a significant risk of serious infection and harm, even though no illnesses or injuries have been reported in the source text. The theoretical hazard and risk-of-harm nature of the defect meet the High severity criterion.
Plain-English summary
First Royal Care Co. LLC, operating as Red Mountain Compounding Pharmacy, is recalling all lots of CALCIUM GLUCONATE 10% INJ (PF), Rx only, due to lack of assurance of sterility. An FDA inspection raised concerns about the product's sterility assurance.
The recalled product was distributed to approximately 494 patients and consumers located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All affected lots remain within their stated expiry periods.
Patients who have received this medication should contact their healthcare provider or pharmacy to discuss next steps. Consult a healthcare professional before making any changes to medication use.
The recalled product
- Product
- CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Hazard
- sterility-assurance
- infection-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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