NDC 16729-512
Atropine Sulfate 0.4 mg per 1 mL injection, solution
On the label: Accord Healthcare Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | No problems foundJul 12, 2024 · 10 inspections |
Recalls
- Jul 3, 2023 · Class II · Accord Healthcare, Inc.
Presence of Particulate Matter: Particulate matter identified as fiber.
Lots: Lot #: M2210154 Exp. date 06/2025; M2212575 Exp. date 08/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Atropine: every company that makes it
- Form
- injection, solution, endotracheal; intramedullary; intramuscular; intravenous; subcutaneous
- Strength
- 0.4 mg per 1 mL
- Approval
- ANDA ANDA213424
- On the market since
- Mar 25, 2021
- Package NDCs
16729-512-0516729-512-43- Official label
- DailyMed (National Library of Medicine), updated Nov 20, 2024
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