The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0195-2017·Announced 2016-12-21

Cantrell Drug Recalls Hydromorphone Syringes Due to Sterility Concerns

Cantrell Drug Company is recalling 935 vials of Hydromorphone HCl 50 mg/50 mL single-dose syringes 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 meets the rubric criteria for a Severe rating.

Plain-English summary

Cantrell Drug Company is recalling 935 single-dose syringes of Hydromorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL). The product is identified by NDC 52533-006-04, Lot 9016, and a beyond-use date of March 7, 2017.

The recall was initiated because the firm lacks assurance of the sterility of the affected drug products. The recall is classified as Class II by the U.S. Food and Drug Administration.

The affected syringes were distributed nationwide. Patients and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.

The recalled product

Product
HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-04
Manufacturer
Cantrell Drug Company
Category
Drug — Sterile Injectable
Hazard
Affected units
935

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: 9016 BUD: 3/7/2017

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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