Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuti...
FDA Recall #D-0633-2024 — Class III — August 7, 2024
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
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.
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
96 vials
Distribution
Product was distributed to one distributor
Code Information
Lot # AD12890, Exp 09/30/2024
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.