The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0184-2017·Announced 2016-12-21

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.

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: 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.

See all 21 products in this recall →

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