Taro Pharmaceuticals Inc. recalls Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc…
- Recall date
- November 6, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0089-2024
- FDA classification
- Class III
- Brand / firm
- Taro Pharmaceuticals Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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