Auro Pharmacies Inc. (doing business as Central Drugs) is recalling approximately 167 vials of Biotin 10 mg/mL Injection (30 mL vials). This prescription medication is being recalled because the product does not meet the required pH label claims, meaning the acidity or alkalinity of the solution is outside of the safe and intended range. These vials were distributed nationwide across the United States between February and April 2019.
Injecting a medication with an incorrect pH level can cause local irritation, pain, or tissue damage at the site of injection. While the risk level is currently categorized as low, using a product that fails to meet chemical specifications may result in an unpredictable physiological response.
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Sources: FDA iRES · Raw API Response
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