Tobramycin Ophthalmic Solution Solution/ Drops
FDA Recall NDC 62332-518
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Tobramycin Ophthalmic Solution (NDC 62332-518). A significant event, classified as Class III, was initiated on Jul 27, 2023 by Alembic Pharmaceuticals Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Impurities/Degradation Specifications
Jul 27, 2023
Aug 23, 2023
82,400 bottles
Recall Profile & Regulatory Data
Event ID
92811
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
ALEMBIC PHARMACEUTICALS, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
Batch or Lot Expiration Information
Lot# : AMR103, Exp: 10/2023
Lot# : AMR201, Exp: 06/2024
Affected Packages Involved in this Recall
62332-518-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
