Recalls / Class II
Class IID-0779-2023
Product
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Affected lot / code info
- All Lots
Why it was recalled
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5605 Centerpoint Ct Ste A, N/A, Gurnee, Illinois 60031-5278
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2023-04-26
- FDA classified
- 2023-06-01
- Posted by FDA
- 2023-06-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0779-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.