Source : 'HBW Insight'
OTC drug recalls in the US ended 2020 much the same way they were for much of the year as additional hand sanitizers made in Mexico were found to contain methanol.
Food and Drug Administration recall records also show that more than 350,000 tubes of clotrimazole anti-fungal topicals made by Taro Pharmaceuticals U.S.A. Inc. and marketed under private label and store brands were found with a degradation impurity.
Additionally, an Indiana manufacturer is recalling between one and four vials of nutritional supplements and pharmaceuticals it supplied to a wellness center owned by the same person after FDA inspectors in October reported “concerns with production processes which cannot assure sterility of products intended to be sterile.”
In addition to more OTC hand sanitizers added to the FDA’s recall records on 23 December (see table linked below), the latest business to announce recalls for hand sanitizers containing methanol, rather than ethyl or isopropyl alcohol as labeled, is Shane Erickson Inc., dba Innovative Marketing Consultants. The Spring Park, MN, firm on the same day said it is recalling a total of four lots of wash-free hand sanitizer in 50-ml, 100- and 300-ml containers branded imc and Thrifty White brand in 300-ml lot containers.
OTC hand sanitizers containing methanol, or wood alcohol, have been found in the US since soon after the FDA in February loosened regulations on manufacturing the products in order to boost supplies as consumer demand soared in response to COVID-19. ()
Recalls of the products account for a large piece of the jump in US drug recalls in 2020 (see related story).
The FDA’s recall records update includes OTC athlete’s foot, jock itch and ringworm treatments containing clotrimazole that Israel pharma Taro Pharmaceutical Industries Ltd.’s US business made for private label and store brand customers including CVS Health, Kaiser Permanente Kroger, Rite Aid and Walmart.
The entries state the reason for the recall as, “unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.”
Health, Beauty And Wellness Product Recalls: 9-30 December, 2020
The information on the recalls includes a total of 361,260 tubes of the products in addition to two entries without product quantities listed.
FDA records also include a form 483 that agency officials sent to Indianapolis firm Advanced Nutricueticals LLC on 29 October following an inspection of the business throughout much of the month. The report includes 15 observations on procedures used by Advanced Nutricueticals staff to prepare nutritional and pharmaceutical formulations that render the products potentially non-sterile.
The information in the FDA recall records for Advanced Nutricueticals products doesn’t reference the form 483, but the products identified in the report track with the names of nutritional and drug ingredients included in the firm’s recall.
Advanced Nutricueticals prepares nutritional and pharmaceutical formulations for the Guyer Institute of Molecular Medicine, which operates at the same address and is owned by the same person, Leonard Guyer, a physician. The institute’s website indicates it provides therapies using dietary supplements as well as pharmaceuticals.
Advanced Nutricueticals is recalling a total of 16 formulations, though the quantity of each is no more than four.
By Malcolm Spicer