The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0191-2017·Announced 2016-12-21

Cantrell Drug Recalls Glycopyrrolate Injection Due to Sterility Concerns

Cantrell Drug Company is recalling specific lots of Glycopyrrolate injection because the firm cannot assure the sterility of the product.

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 FDA classified this recall as 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 no specific injuries are reported in the text, the lack of sterility assurance in an IV product is a significant hazard.

Plain-English summary

Cantrell Drug Company is recalling 48,592 syringes of Glycopyrrolate 1 mg/5 mL Injection Solution. The product is distributed nationwide and is intended for intravenous use in hospitals and offices only. The recall involves four specific lots: 9006, 8757, 8954, and 9174.

The recall is being conducted because the firm lacks assurance of the sterility of the selected sterile drug products. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare facilities and pharmacies should check their inventory for the affected NDC 52533-028-15 and the specific lot numbers listed above. Patients who have received this medication should contact their healthcare provider for guidance.

The recalled product

Product
Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-028-15
Manufacturer
Cantrell Drug Company
Category
Drug — Sterile Injection
Hazard
Affected units
48,592

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 (4)

  • Lot: 9006 BUD: 1/20/2017
  • Lot: 8757 BUD: 11/30/2016
  • Lot: 8954 BUD: 1/6/2017
  • Lot: 9174 BUD: 2/20/2017

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 →

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