Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling 96 vials of Hydrocortisone 1% & Acetic Acid 2% Otic Solution, a prescription ear medication. This recall was issued because the product failed stability testing, showing slightly lower than required levels of hydrocortisone and the presence of impurities. Using a product that does not meet chemical specifications may result in the medication being less effective at treating ear inflammation and infection.
The reduced level of active ingredient and the presence of degradation products mean the medication may not work as intended. While the risk is considered low, patients using the affected drops may experience inadequate treatment of their condition.
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Quantity: 96 vials. Manufactured by Taro Pharmaceuticals, Inc. in Canada.
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Sources: FDA iRES · Raw API Response
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