FDA recall D-0089-2024

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

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-11-06

Report date

2023-11-15

Termination date

2024-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brampton, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0089-2024