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

FDA recall notice · announced February 15, 2023 · Akorn

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot: 081031A, Exp 2/28/2023
Quantity: 45,117 Bottles
Status: Ongoing
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.