NDC 16729-473

Glycopyrrolate 0.2 mg per 1 mL injection

On the label: Accord Healthcare Inc..

Where it's made

Recalls

• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: R2200436, Exp. Date 1/31/2024, R2200159, Exp. Date 1/31/2024, R2200166, Exp. Date 1/31/2024, R2200618, Exp. Date 4/30/2024, R2201290, Exp. Date 8/31/2024, R2201324, Exp. Date 8/31/2024
• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: R2200509, Exp. Date 4/30/2024, R2200507, Exp. Date 4/30/2024, R2200508, Exp. Date 4/30/2024
• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: R2200259, Exp. Date 2/29/2024, R2200258, Exp. Date 2/29/2024, R2200617, Exp. Date 4/30/2024, R2201308, Exp. Date 8/31/2024
• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: R2200431, Exp. Date 7/31/2023, R2200439, Exp. Date 9/30/2023
• Jan 28, 2021 · Class III · Accord Healthcare, Inc.
  Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
  Lots: Lot: M2013645 Exp. Aug. 2022

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Glycopyrronium: every company that makes it

Form

injection, intramuscular; intravenous

Strength

0.2 mg per 1 mL

Approval

ANDA ANDA213238

On the market since

Dec 10, 2020

Package NDCs

16729-473-03

Official label

DailyMed (National Library of Medicine), updated Oct 17, 2025

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