Drug product
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
D-0577-2018
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 79278
- Status
- Terminated
- Classification
- Class III
- Quantity
- 31,812 bottles
- Official record key
drug-enforcement:D-0577-2018
Official wording
Reason: Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Code information: Lot: 011037A
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Stability Specification