The Recall Desk
SevereFDA (Drugs)·D-1065-2017·Announced 2017-08-16

Cantrell Recalls Glycopyrrolate Injection Syringes Due to Sterility Concerns

Cantrell Drug Company is recalling 75,840 syringes of Glycopyrrolate Injection Solution nationwide because of 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 serious injury or infection.

Plain-English summary

Cantrell Drug Company is recalling 75,840 single-dose syringes of Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL), prescription only. The recall was initiated due to a lack of sterility assurance in the product.

The affected product is identified by NDC 52533-028-15. The recall covers specific lots with expiration dates ranging from July 27, 2017, to November 19, 2017. The product was distributed nationwide within the United States.

Healthcare providers and patients should stop using the recalled syringes and contact Cantrell Drug Company for further instructions or a replacement.

The recalled product

Product
Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-15
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable
Hazard
Affected units
75,840

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 #: 9783
  • BUD: 7/27/2017
  • 9801
  • BUD: 7/29/2017
  • 9807
  • BUD: 7/30/2017
  • 9847
  • BUD: 8/4/2017
  • 9954
  • BUD: 8/20/2017
  • 10022
  • BUD: 9/1/2017
  • 10052
  • BUD: 9/6/2017
  • 10063
  • BUD: 9/7/2017
  • 10086
  • BUD: 9/9/2017
  • 10108
  • BUD: 9/13/2017

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 →

Related recalls

Same manufacturer · Cantrell Drug Company

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Same hazard · lack of sterility

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