The Recall Desk
SevereFDA (Drugs)·D-1066-2017·Announced 2017-08-16

Cantrell Recalls Glycopyrrolate Injection Syringes Due to Sterility Concerns

Cantrell Drug Company is recalling 21,080 syringes of Glycopyrrolate Injection Solution due to a lack of sterility assurance.

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 and involves a lack of sterility assurance in an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Cantrell Drug Company is recalling 21,080 syringes of Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe. The recall was initiated because of a lack of sterility assurance for the product.

The affected product is identified by NDC 52533-028-16. The recall includes specific lots with expiration dates ranging from July 26, 2017, to November 8, 2017. The product was distributed nationwide within the United States.

Consumers and healthcare providers should stop using the recalled syringes and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-16
Affected units
21,080

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 (20)

  • Lot #: 9781
  • BUD: 7/26/2017
  • 9784
  • BUD: 7/27/2017
  • 9822
  • BUD: 8/2/2017
  • 9852
  • BUD: 8/5/2017
  • 10061
  • BUD: 9/7/2017
  • 10105
  • BUD: 9/13/2017
  • 10150
  • BUD: 9/17/2017
  • 10178
  • BUD: 9/22/2017
  • 10185
  • BUD: 9/23/2017
  • 10501
  • BUD: 11/8/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 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 18 products in this recall →