Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ
Summary
The FDA issued a Class III for Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: by ALEMBIC PHARMACEUTICALS, INC.. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-1086-2023
Action Date
2023-08-23
Status
Ongoing
Category
drug
Product Description
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
Lot/Code Info: Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024
Quantity Affected: 82,400 bottles
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-27
Company
Bedminster, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
ALEMBIC PHARMACEUTICALS, INC. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ALEMBIC PHARMACEUTICALS, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ALEMBIC PHARMACEUTICALS, INC. have FDA actions?
ALEMBIC PHARMACEUTICALS, INC. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1086-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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