Drug product
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
D-1086-2023
Product summary
- Event
- Event 92811
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 82,400 bottles
- Official record key
drug-enforcement:D-1086-2023
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications