Akorn Inc. has recalled approximately 15,322 bottles of Hydrocortisone and Acetic Acid Otic Solution, USP (10 mL), which is used to treat ear infections. This recall affects one specific lot of the prescription medication because routine stability testing found that the active ingredient, hydrocortisone, was falling below the required strength levels. While no injuries or adverse events have been reported, consumers should contact their healthcare provider or pharmacist regarding the effectiveness of their medication.
The drug is sub-potent, meaning it contains less than the intended amount of hydrocortisone. This may result in the medication being less effective at treating the inflammation associated with ear infections, potentially leading to a longer recovery time or worsening of symptoms.
Pharmacy refund and medical consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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