The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0398-2023·Announced 2023-03-08

Glycopyrrolate injection recalled due to manufacturing practice deviations

Accord Healthcare recalls Glycopyrrolate injection due to manufacturing practice deviations found during FDA inspection. The recall affects 3,164 vials distributed in the US, 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for manufacturing practice deviations identified during inspection. No illnesses, injuries, or deaths have been reported. The hazard is based on process deviations rather than an identified defect, making this a precautionary recall.

Plain-English summary

Glycopyrrolate injection (1 mg/5 mL, 0.2 mg/mL) manufactured by Accord Healthcare, Inc. is being recalled due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The recall affects 3,164 vials distributed across four affected batches with expiration dates ranging from February 2024 to August 2024.

The recalled product was distributed throughout the United States, including Puerto Rico and Canada. Healthcare facilities and distributors are advised to identify and quarantine affected inventory from batches R2200259, R2200258, R2200617, and R2201308.

Healthcare providers and patients with this medication should contact their supplier or healthcare provider for guidance on next steps. No illnesses or injuries related to this product have been reported.

The recalled product

Product
GLYCOPYRROLATE (GLYCOPYRROLATE)
Brand
GLYCOPYRROLATE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Injection
Hazard
Affected units
3,164

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 (7)

  • Batches: R2200259
  • Exp. Date 2/29/2024
  • R2200258
  • R2200617
  • Exp. Date 4/30/2024
  • R2201308
  • Exp. Date 8/31/2024

UPCs (6)

  • 0316729474054
  • 0316729472302
  • 0316729473316
  • 0316729471633
  • 316729473316
  • 316729473033

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 →

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