FDA-Drug2024-08-21Class III
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
Taro Pharmaceuticals U.S.A., Inc.
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.
Sold states
Product was distributed to one distributor
Affected count
96 vials
Manufactured in
3 Skyline Dr, Hawthorne, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0633-2024Don't want to check this manually?
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