Cantrell Drug Recalls Heparin Sodium Bags Due to Sterility Concerns
Cantrell Drug Company is recalling 150 bags of Heparin Sodium 5,000 USP Units in 0.9% Sodium Chloride 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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death if administered.
Plain-English summary
Cantrell Drug Company is recalling 150 bags of Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL Bag (5 USP units/mL). The product is a single-dose bag intended for hospital or office use only and is an injection solution for intravenous use. The recall is limited to Lot 167081 and was distributed nationwide.
The recall was initiated because the firm is recalling select sterile drug products due to a lack of assurance of sterility. This classification indicates that the product may not be sterile as required for its intended use.
Healthcare facilities and pharmacies should stop using the affected product and contact Cantrell Drug Company for further instructions. Consumers should not use this product if they have it in their possession, as it is intended for professional medical use only.
The recalled product
- Product
- Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Single-Dose Bag.,Hospital/Office Use Only, Injection Solution For IV Use, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-097-24
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Injectable Solution
- Affected units
- 150
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: 167081
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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