Recalls / Class III
Class IIID-0265-2023
Product
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
- Affected lot / code info
- Lot: 081031A, Exp 2/28/2023
Why it was recalled
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5605 Centerpoint Ct Ste A, Gurnee, Illinois 60031-5278
Distribution
- Quantity
- 45,117 Bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2023-01-30
- FDA classified
- 2023-02-08
- Posted by FDA
- 2023-02-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0265-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.