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US/Silver Spring: Procaps SA de CV, a San Salvador, El Salvador establishment, recalls certain batch/lots of Laboratorios Lopez’s Bacaolinita Supplements from the American marketplace due to suspected mislabeling and consequential undeclared APEG-40 Hydrogenated Castor Oil, a substance for which safety date for internal ingestion is insufficient and a possible skin allergen and possible trigger of Anaphylaxis, a serious and potential fatal situation, requiring immediate medical intervention to minimize pain and suffering as well as prevent life-altering injury or death.
FDA: https://rb.gy/slv39
Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplements are subject to this recall:
Filed under: Allergens & Intolerances, Anaphylaxis, APEG-40, Chemical contamination hazard, Dietary Supplements, Drugs, Food & Drink, US FDA | Tagged: Anaphylaxis hazard, APEG-40 Hydrogenated Castor Oil, Bacaolinita Supplements, children, Dietary Supplements, drug, Laboratorios Lopez's Bacaolinita Supplements, Nutritional Supplements, Procaps SA de CV, Recalls Direct RIN: 17165-2023, Recalls Direct RIN: 17227-2023, US FDA, US Food and Drug Administration | Leave a comment »