Cantrell Drug Recalls Hydromorphone Injection Vials Due to Sterility Concerns
Cantrell Drug Company is recalling 93 vials of Hydromorphone HCl injection solution nationwide due to a lack of assurance of sterility.
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, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or high-risk contamination scenarios.
Plain-English summary
Cantrell Drug Company is recalling 93 vials of Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vials. The product is a single-dose injection solution intended for slow intravenous use and is available by prescription only. The specific lot number is 163941, and the National Drug Code (NDC) is 52533-006-10.
The recall was initiated because the firm lacks assurance of the sterility of the drug products. This classification indicates a potential risk that the sterile environment required for the product was not maintained or verified.
The affected vials were distributed nationwide. Healthcare providers and patients should discontinue use of the recalled product and contact their pharmacist or the recalling firm for further instructions on returns or replacements.
The recalled product
- Product
- Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-10
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Injection Solution
- Hazard
- Affected units
- 93
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: 163941
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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