Class IIICompleted

Hydrocortisone 1% & Acetic Acid 2% Otic Solution recall

FDA recall D-0633-2024 · initiated Aug 7, 2024

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

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.

Details

Product: 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
Recalling company: Taro Pharmaceuticals U.S.A., Inc.
Classification: Class III
Status: Completed
Type: Voluntary: Firm initiated
Distribution: Product was distributed to one distributor
Initiated: Aug 7, 2024
FDA report date: Aug 21, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0633-2024 ↗

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