The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1067-2017·Announced 2017-08-16

Cantrell Drug Recalls Glycopyrrolate Injection Syringes Due to Sterility Concerns

Cantrell Drug Company is recalling specific lots of Glycopyrrolate Injection Solution due to a lack of sterility assurance. The affected syringes were 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 and involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Cantrell Drug Company is voluntarily recalling specific lots of Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringes. The recall was initiated because of a lack of sterility assurance for the affected product.

The recalled product includes NDC 52533-028-45. The specific lots affected are 9868 (Best Use Date: 8/9/2017), 9872 (Best Use Date: 8/10/2017), and 10318 (Best Use Date: 10/7/2017). A total of 5,245 syringes were distributed nationwide within the United States.

Healthcare providers and patients should check their inventory and medication records for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be discontinued and returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-45
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable Medication
Hazard
Affected units
5,245

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 (6)

  • Lot #: 9868
  • BUD: 8/9/2017
  • 9872
  • BUD: 8/10/2017
  • 10318
  • BUD: 10/7/2017

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 →

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