FDA-Drug2018-03-14Class III

Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05

Akorn, Inc.
Hazard

Failed Stability Specification: OOS low viscosity results discovered during retain testing.

Sold states
Nationwide in the USA
Affected count
31,812 bottles
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0577-2018

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