November 2023 FDA Recall Hydrocortisone And Acetic Acid by Taro Pharmaceuticals Inc.
D-0089-2024 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Taro Pharmaceuticals Inc. on November 6, 2023 for the product Hydrocortisone And Acetic Acid. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0089-2024

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.
Initiated
11-06-2023
Reported
11-15-2023
Quantity
11,196 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93337
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Taro Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-27-2024
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# AC86809, AC86812, Exp Date: 01/31/2024

Affected Packages Involved in this Recall

51672-3007-1 Hydrocortisone And Acetic Acid