Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Akorn | Location not on file | Makes it, tests it and sterilizes it | Not inspected on record |
| Akorn | Location not on file | Packages it and labels it | Not inspected on record |
Recalls
- Jan 30, 2023 · Class III · Akorn, Inc.
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Lots: Lot: 081031A, Exp 2/28/2023 - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: 071520A - Feb 21, 2018 · Class III · Akorn, Inc.
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Lots: Lot: 011037A
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
- Strength
- 10 mg per 1 mL
- Approval
- NDA NDA206289
- On the market since
- Jul 18, 2014
- Package NDCs
17478-215-0217478-215-0517478-215-15- Official label
- DailyMed (National Library of Medicine), updated Jul 1, 2022
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?