Cantrell Drug Recalls Ropivacaine HCl Bags Due to Sterility Concerns
Cantrell Drug Company is recalling 87 bags of Ropivacaine HCl 0.25% due to a lack of assurance of sterility. The product is intended for epidural use only.
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 involves a lack of assurance of sterility in a drug intended for epidural use, which poses a significant risk of serious injury or infection.
Plain-English summary
Cantrell Drug Company is recalling 87 bags of Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only. 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 169064 and NDC 52533-185-75. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and patients should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-185-75
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Sterile Injectable
- Hazard
- Affected units
- 87
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: 169064
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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