NDC 71872-7238
Glycopyrrolate 0.2 mg per 1 mL injection
On the label: Medical Purchasing Solutions, LLC.. It's repackaged: Medical Purchasing Solutions, LLC. rebottles it from Accord Healthcare Inc.'s NDC 16729-471.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | No problems foundJul 12, 2024 · 10 inspections |
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- Medical Purchasing Solutions, LLC, Scottsdale, AZ, United States · repackages it
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 17, 2020
- Package NDCs
71872-7238-1- Official label
- DailyMed (National Library of Medicine), updated May 8, 2023
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