Cantrell Drug Recalls Rocuronium Bromide Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling 5,067 syringes of Rocuronium Bromide 50 mg/5 mL injection solution nationwide 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 involves a lack of assurance of sterility in a sterile drug product, which poses a significant risk of serious health consequences such as infection, aligning with the 'Severe' criteria for significant injury risk.
Plain-English summary
Cantrell Drug Company is recalling 5,067 syringes of Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only. The product is identified by NDC 52533-064-15 and Lot 8995. The recall is being conducted because the firm lacks assurance of the sterility of the product.
The affected syringes were distributed nationwide. The source text does not specify the exact dates of distribution or the specific healthcare facilities where the product was shipped. No illnesses or injuries have been reported in the source text.
Healthcare providers and patients should stop using the affected syringes immediately. Users should contact their healthcare provider or the recalling firm for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-064-15
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Sterile Injection
- Affected units
- 5,067
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: 8995
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 →Related recalls
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