FDAFDA · Food and drugs·Recall number D-0633-2024
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
Published August 21, 2024 · Recall initiated: August 7, 2024
Status when published: Completed — 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 results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Distributor
- Product was distributed to one distributor
- Lot
- Lot # AD12890, Exp 09/30/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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