The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0397-2023·Announced 2023-03-08

Prescription Glycopyrrolate Injection Recalled Due to Manufacturing Process Deviations

Accord Healthcare is recalling Glycopyrrolate Injection due to manufacturing process deviations found during FDA inspection. The recall involves 5,273 vials distributed across the United States, Puerto Rico, and Canada.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall triggered by manufacturing process (CGMP) deviations identified during inspection. No illnesses or injuries have been reported. The recall represents a potential risk without confirmed harm, placing it in the High severity category.

Plain-English summary

Accord Healthcare, Inc. is recalling Glycopyrrolate Injection, USP (0.4 mg/2 mL), a prescription injectable drug. The recall involves 5,273 vials from three batches (R2200509, R2200507, R2200508), all expiring April 30, 2024.

The recall was initiated following an FDA inspection that identified deviations from Current Good Manufacturing Practice (CGMP). These manufacturing deviations created a potential risk that the drug may not meet required quality or safety standards.

The affected product was distributed throughout the United States, including Puerto Rico, and in Canada under NDC codes 16729-472-30 (individual vials) and 16729-472-08 (cartons).

Patients and healthcare facilities should check their inventory and records for the affected batch numbers. Those who may have received or administered doses from these batches should consult with their healthcare provider about appropriate follow-up actions.

The recalled product

Product
GLYCOPYRROLATE (GLYCOPYRROLATE)
Brand
GLYCOPYRROLATE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Injectable / Prescription
Hazard
Affected units
5,273

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)

  • Batches: R2200509
  • Exp. Date 4/30/2024
  • R2200507
  • R2200508

UPCs (6)

  • 0316729474054
  • 0316729472302
  • 0316729473316
  • 0316729471633
  • 316729472302
  • 316729472081

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, Inc. 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 67 products in this recall →

Related recalls

Same brand · GLYCOPYRROLATE

Same manufacturer · Accord Healthcare, Inc.

See all →

Same hazard · manufacturing defect

See all →

Similar recalls