Tobramycin Opthalmic Solution USP recall: Impurity Out of Spec
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
Why was Tobramycin Opthalmic Solution USP recalled?
Failed Impurities/Degradation Specifications
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024
- Product
- Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
- Recalling firm
- ALEMBIC PHARMACEUTICALS, INC.
- Quantity
- 82,400 bottles
- Distribution
- Nationwide in the USA
- Recall date
- August 23, 2023
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)