FDAFDA · Food and drugs·Recall number D-0089-2024
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
Published November 15, 2023 · Recall initiated: November 6, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- HYDROCORTISONE AND ACETIC ACID
- Manufacturer
- Taro Pharmaceuticals Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot# AC86809, AC86812, Exp Date: 01/31/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- Canada
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.