The Recall Desk
HighFDA (Drugs)·D-0399-2023·Announced 2023-03-08

Glycopyrrolate Injection Recalled Due to Manufacturing Quality Deviations

Accord Healthcare is recalling Glycopyrrolate Injection (4 mg/20 mL) from two batches due to CGMP deviations identified during FDA inspection. No illnesses have been reported.

What this means for you

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: FDA Class II recall due to manufacturing quality deviations (CGMP) identified during regulatory inspection. No illnesses or injuries have been reported; the hazard relates to potential quality and safety risks from manufacturing defects.

Plain-English summary

Accord Healthcare, Inc. is recalling Glycopyrrolate Injection, USP (4 mg/20 mL, 0.2 mg/mL) across the United States, Puerto Rico, and Canada. The recall affects 322 vials from two batches: R2200431 (expiration 7/31/2023) and R2200439 (expiration 9/30/2023). The product is manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India.

The recall was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations in the manufacturing process. CGMP standards ensure drugs are manufactured under safe, quality conditions. No illnesses or injuries related to this product have been reported.

If you have received this product, do not use it. Patients and healthcare providers should consult with a pharmacist or healthcare provider about alternative treatments. This product may not meet established quality standards due to the identified manufacturing deviations.

The recalled product

Product
GLYCOPYRROLATE (GLYCOPYRROLATE)
Brand
GLYCOPYRROLATE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Injectable
Hazard
Affected units
322

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: R2200431
  • Exp. Date 7/31/2023
  • R2200439
  • Exp. Date 9/30/2023

UPCs (6)

  • 0316729474054
  • 0316729472302
  • 0316729473316
  • 0316729471633
  • 316729474054
  • 316729474030

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 →