Drug product
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
D-0169-2025
Product summary
- Event
- Event 95997
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,870 bottles
- Official record key
drug-enforcement:D-0169-2025
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: A240211, Exp. Date April 2026
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications