NDC 70069-716
Atropine Sulfate 10 mg per 1 mL solution/ drops
On the label: Somerset Therapeutics, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Somerset Therapeutics Private Limited | Bengaluru, India | Makes it, tests it, packages it and labels it | Serious problems, FDA actionFeb 21, 2025 · 10 inspections, 4 with FDA action |
Recalls
- Dec 16, 2024 · Class III · Somerset Therapeutics Llc
Failed Impurities/Degradation Specifications
Lots: Lot #: A240211, Exp. Date April 2026
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
- solution/ drops, ophthalmic
- Strength
- 10 mg per 1 mL
- Approval
- ANDA ANDA217791
- On the market since
- May 24, 2024
- Package NDCs
70069-716-01- Official label
- DailyMed (National Library of Medicine), updated May 24, 2024
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