The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0194-2017·Announced 2016-12-21

Cantrell Drug Recalls Hydromorphone Syringes Due to Sterility Concerns

Cantrell Drug Company is recalling 2,509 single-dose Hydromorphone HCl syringes 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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterile drug products where sterility assurance is compromised.

Plain-English summary

Cantrell Drug Company is recalling 2,509 single-dose syringes of Hydromorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL). The product is identified by NDC 52533-002-03 and Lot 8742. The recall is being conducted because the firm lacks assurance of the sterility of these drug products.

The affected syringes were distributed nationwide. The source text does not specify specific states, facilities, or dates of distribution. No illnesses or injuries have been reported in the source text.

Healthcare providers and patients should stop using the affected syringes and contact their pharmacist or the recalling firm for further instructions. Consumers should not use the product if they have it in their possession.

The recalled product

Product
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-002-03
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable Sterile Drug
Hazard
Affected units
2,509

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: 8742

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

Same manufacturer · Cantrell Drug Company

See all →

Same hazard · sterility

See all →

Similar recalls