Recalls / Class III

Class IIID-0633-2024

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

Affected lot / code info

Lot # AD12890, Exp 09/30/2024

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.

Recalling firm

Firm

Taro Pharmaceuticals U.S.A., Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

3 Skyline Dr, Hawthorne, New York 10532-2174

Distribution

Quantity

96 vials

Distribution pattern

Product was distributed to one distributor

Timeline

Recall initiated

2024-08-07

FDA classified

2024-08-13

Posted by FDA

2024-08-21

Status

Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-0633-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.