Drug 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
D-0265-2023
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 91580
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 45,117 Bottles
- Official record key
drug-enforcement:D-0265-2023
Official wording
Reason: Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Code information: Lot: 081031A, Exp 2/28/2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out of specification