Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Ta...
FDA Recall #D-0089-2024 — Class III — November 6, 2023
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
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.
Recalling Firm
Taro Pharmaceuticals Inc. — Brampton
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
11,196 bottles
Distribution
Nationwide in the USA
Code Information
Lot# AC86809, AC86812, Exp Date: 01/31/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated