The Recall Desk
SevereFDA (Drugs)·D-0200-2017·Announced 2016-12-21

Cantrell Drug Recalls Neostigmine Methylsulfate Syringes Due to Sterility Concerns

Cantrell Drug Company is recalling specific lots of Neostigmine Methylsulfate injection syringes because the firm cannot ensure the products are sterile.

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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the text, the agency classification and the nature of the hazard (sterility) align with the Severe criteria for Class II recalls.

Plain-English summary

Cantrell Drug Company is recalling 24,547 single-dose syringes of Neostigmine Methylsulfate 5 mg/5 mL Injection Solution. The affected products are distributed nationwide and include Lot 8997 with a best-use date of 12/1/2016 and Lot 9246 with a best-use date of 1/23/2017.

The recall was initiated due to a lack of assurance of sterility. The firm is recalling these select sterile drug products to address this quality concern.

Healthcare providers and patients should stop using the affected syringes and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose Syringe, For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-046-15
Affected units
24,547

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 (2)

  • Lot: 8997 BUD: 12/1/2016
  • Lot: 9246 BUD: 1/23/2017

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 →