Glenmark Pharmaceuticals Inc., USA is voluntarily recalling 38,496 bottles of Fluocinolone Acetonide Oil, 0.01% (Ear Drops), a prescription medication used for ear conditions. The recall was initiated because testing showed the product failed to meet specifications for isopropyl alcohol, an inactive ingredient. No injuries or adverse incidents have been reported to date. Consumers should check their medicine cabinets for the affected 1 oz. (20 mL) bottles with specific lot numbers and expiration dates.
The product failed testing for the concentration of isopropyl alcohol, which is an inactive ingredient. Using a medication that does not meet chemical specifications may result in suboptimal treatment or unintended side effects, though no injuries have been reported.
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Quantity: 38,496 bottles; Manufactured by: Glenmark Pharmaceuticals Ltd., India
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.
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Sources: FDA iRES · Raw API Response
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