API Solutions Inc. is recalling 21 units of Estriol USP41 Micro (25 Grams) and Azelaic Acid 99.0+% Micro (500 Grams) because the products were manufactured under conditions that deviated from Current Good Manufacturing Practice (cGMP) standards. These products are active pharmaceutical ingredients used in compounding medications. The recall affects 20 bottles of Estriol and 1 bottle of Azelaic Acid distributed to Alabama, Arizona, Colorado, Florida, and Virginia. Consumers and pharmacies should stop using these specific lots and contact their healthcare provider or pharmacist for guidance.
Manufacturing deviations (cGMP) mean the purity, identity, or quality of the drug ingredients cannot be guaranteed. This could lead to medications that are ineffective or contain unintended contaminants, potentially causing adverse health effects for patients using compounded formulations.
Drug recall remedy
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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