Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, O
Summary
The FDA issued a Class III for Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: by Taro Pharmaceuticals U.S.A., Inc.. Reason: Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established lev.
Details
Source
Drug Recall
External ID
D-0633-2024
Action Date
2024-08-21
Status
Completed
Category
drug
Product Description
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01
Lot/Code Info: Lot # AD12890, Exp 09/30/2024
Quantity Affected: 96 vials
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Distribution
Product was distributed to one distributor
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-07
Company
Hawthorne, NY
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 28 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Taro Pharmaceuticals U.S.A., 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 (Taro Pharmaceuticals U.S.A., 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 U.S.A., Inc. have FDA actions?
Taro Pharmaceuticals U.S.A., 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-0633-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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