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HBW Regulatory Roundup: Spiked 'Vitamin C' Found, SC Johnson Facility GMP Problems, AHPA Labeling Guidance

Fitoterapia USA recalls 190,000 bottles of Metro Macho Artificial Passion Fruit Flavored Vitamin C Liquid Supplement tainted with tadalafil; FDA sends GMP warning letter to SC Johnson facility making antimicrobial hand soaps ; and AHPA revises its herbal supplement labeling guidance.

A product marketed as a liquid vitamin C joins the list of products the US Food and Drug Administration has found spiked with the erectile dysfunction drug tadalafil or its analogs. Fitoterapia USA Inc. is recalling 190,000 bottles of Mero Macho Artificial Passion Fruit Flavored Vitamin C Liquid Supplement because the presence of tadalafil in Macho renders it an unapproved drug subject to recall, said the agency on 17 September. The product, marketed in an 8.5-fluid ounce bottle, was distributed nationwide to retail stores and through online sales since April. Pembroke Pines, Fla.-based Fitoterapia has not received any reports of adverse events related to the affected lots, ZD-160-18, expiration 09-07-2019; ZD-078-19, expiration 27-04-2020; ZD-159-17, expiration 31-05-2018.

The FDA regularly finds products marketed as supplements but spiked with drugs, most often indicated for sexual enhancement, weight loss or strength training. However, those products typically are not labeled...

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