Medications & Supplements/Prescription Drugs

Tobramycin Ophthalmic Solution Recalled for Failed Impurity Specifications

Agency Publication Date: August 17, 2023

Summary

Alembic Pharmaceuticals, Inc. is recalling 82,400 bottles of Tobramycin Ophthalmic Solution USP (0.3%), a prescription eye drop medication. The recall was initiated because the product failed to meet standard specifications for impurities and degradation during stability testing. The affected product is packaged in 5mL bottles and includes lots AMR103 and AMR201.

Risk

Using eye drops that have degraded or contain impurities beyond established limits may result in the medication being less effective or could potentially cause irritation. The risk of serious adverse health consequences from this specific issue is considered low.

What You Should Do

This recall affects Alembic Pharmaceuticals Tobramycin Ophthalmic Solution USP, 0.3%, packaged in 5mL bottles (NDC 62332-518-05).
Identify if your medication is affected by checking the packaging for lot number AMR103 with expiration date 10/2023, or lot number AMR201 with expiration date 06/2024.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Tobramycin Opthalmic Solution USP, 0.3% (5mL bottle)

Variants: 0.3%, 5mL bottle, Rx only

Lot Numbers:

AMR103 (Exp: 10/2023)

AMR201 (Exp: 06/2024)

NDC:

62332-518-05

Recall #: D-1086-2023; Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92811

Status: Active

Manufacturer: ALEMBIC PHARMACEUTICALS, INC.

Manufactured In: United States

Units Affected: 82,400 bottles

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Alembic Pharmaceuticals Tobramycin Ophthalmic Solution USP, 0.3%, packaged in 5mL bottles (NDC 62332-518-05).

Identify if your medication is affected by checking the packaging for lot number AMR103 with expiration date 10/2023, or lot number AMR201 with expiration date 06/2024.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.