Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc.
Summary
The FDA issued a Class III for Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX by Taro Pharmaceuticals Inc.. Reason: Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established l.
Details
Source
Drug Recall
External ID
D-0089-2024
Action Date
2023-11-15
Status
Terminated
Category
drug
Product Description
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
Lot/Code Info: Lot# AC86809, AC86812, Exp Date: 01/31/2024
Quantity Affected: 11,196 bottles
Reason for Recall
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-06
Company
Brampton
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 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (Taro 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 Taro Pharmaceuticals Inc. have FDA actions?
This is the only FDA action we have on record for Taro Pharmaceuticals Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0089-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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