Cantrell Drug Recalls Calcium Chloride Bags Due to Sterility Concerns
Cantrell Drug Company is recalling 80 bags of Calcium Chloride 1 g/50 mL due to a lack of assurance of sterility.
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: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury reports or structural defects are rated Severe. While specific injury reports are not detailed in the text, the lack of sterility assurance in a sterile drug product is a significant hazard that aligns with the Severe classification for Class II recalls involving potential serious harm.
Plain-English summary
Cantrell Drug Company is recalling 80 single-dose bags of Calcium Chloride 1 g/50 mL added to 5% Dextrose (20 mg/mL). The product is prescription-only and intended for hospital or office use. The recall is being conducted because the firm lacks assurance of the sterility of the drug product.
The affected product is identified by Lot 169170 and NDC 52533-175-37. The recall is classified as Class II by the U.S. Food and Drug Administration. The product was distributed nationwide.
Healthcare facilities and pharmacies should stop using the affected product and contact Cantrell Drug Company for further instructions. Consumers should not use this product, which is restricted to professional medical settings.
The recalled product
- Product
- Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only, Hospital/Office Use Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-175-37
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Sterile Injectable
- Hazard
- Affected units
- 80
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)
- Lot: 169170
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 recalled by Cantrell Drug Company 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.
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