August 2024 FDA Recall Drug by Taro Pharmaceuticals U.s.a., Inc.
D-0633-2024 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Taro Pharmaceuticals U.s.a., Inc. on August 7, 2024 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Product was distributed to one distributor and the recall is currently completed.

Recall Number: D-0633-2024

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.
Initiated
08-07-2024
Reported
08-21-2024
Quantity
96 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95125
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Taro Pharmaceuticals U.S.A., 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.
Product was distributed to one distributor
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# AD12890, Exp 09/30/2024