FDA Recall D-0265-2023
Akorn, Inc. · Gurnee, IL
Class III Ongoing 1200 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Reason for recall
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Recall record
- Recall number
D-0265-2023- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall initiated
- 2023-01-30
- Classified by FDA Center
- 2023-02-08
- FDA published
- 2023-02-15
- Recalling firm
- Akorn, Inc.
- Firm location
- Gurnee, IL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.