The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0188-2017·Announced 2016-12-21

Cantrell Drug Recalls Fentanyl Citrate Bags Due to Sterility Concerns

Cantrell Drug Company is recalling 471 bags of Fentanyl Citrate 1,500 mcg 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a sterile drug product, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Cantrell Drug Company is recalling 471 bags of Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Single-Dose Bag, Rx Only. The product is identified by NDC 52533-024-35 and Lot 9002.

The recall was initiated because the firm is recalling select sterile drug products due to a lack of assurance of sterility. The affected products were distributed nationwide.

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
Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-35
Manufacturer
Cantrell Drug Company
Category
Drug — Sterile Drug Product
Hazard
Affected units
471

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: 9002

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 →

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