Cantrell Drug Recalls Morphine Sulfate Bags Due to Sterility Concerns
Cantrell Drug Company is recalling 1,748 bags of Morphine Sulfate 1 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.
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 or hospitalization reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the text, the 'Lack of Assurance of Sterility' for a potent opioid injection represents a significant risk of serious harm (sepsis, death) that aligns with the Severe tier for Class II drug recalls where the hazard is not merely theoretical or cosmetic.
Plain-English summary
Cantrell Drug Company is recalling 1,748 bags of Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Single-Dose Bags. The recall is being conducted because the firm lacks assurance of the sterility of these sterile drug products.
The affected product is identified by Lot 8625 and NDC 52533-160-75. It is a prescription-only medication manufactured by Cantrell Drug Company in Little Rock, Arkansas. The recall covers units distributed nationwide.
Healthcare providers and patients should stop using the affected product and contact their healthcare provider or the manufacturer for further instructions. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the product might cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-160-75
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Sterile Injectable
- Affected units
- 1,748
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: 8625
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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