The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0198-2017·Announced 2016-12-21

Cantrell Drug Recalls Midazolam HCl Syringes Due to Sterility Concerns

Cantrell Drug Company is recalling 37 syringes of Midazolam HCl 50 mg/50 mL due to a lack of assurance of sterility. The product was distributed nationwide.

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. According to the rubric, an FDA Class II recall involving a sterile drug product where sterility is not assured is categorized as Severe due to the significant risk of infection or injury.

Plain-English summary

Cantrell Drug Company is recalling 37 single-dose syringes of Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL). The product is identified by NDC 52533-001-04 and Lot 169619. It is intended for hospital or office use only and is available by prescription.

The recall was initiated because the firm lacks assurance of the sterility of the product. The affected syringes were distributed nationwide.

Healthcare providers and facilities should stop using the affected product and contact Cantrell Drug Company for further instructions. Consumers should not use this product and should consult their healthcare provider if they have questions.

The recalled product

Product
Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-001-04
Manufacturer
Cantrell Drug Company
Category
Drug — Sterile Injectable
Hazard
Affected units
37

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: 169619

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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