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[6/29/2018] FDA advises health care professionals not to use MedGyn Products’ Monsel’s Solution (ferric subsulfate 20%) because the drug product was made under poor conditions . The solution is manufactured by BioDiagnostics International, Brea, California, and distributed by MedGyn Products, Inc., Addison, Illinois. BioDiagnostics notified MedGyn of the recall of all lots of Monsel’s Solution on June 11, 2018. However, MedGyn has not yet notified its customers to remove any distributed drug product from the market. Monsel’s Solution is used to stop bleeding after medical procedures, such as a colposcopy and a biopsy. The solution is sold in a carton containing 12 single application vials and 12 applicators, 8 mL each, NDC 42721-112-08. Health care professional s should immediately check their medical supplies, ...

[4/1/2020] FDA reminds patients not to use any drugs manufactured by Herbal Doctor Remedies, Monterey Park, California, because these drugs were not manufactured under good manufacturing practices.  During FDA’s March 2020 follow-up inspection, FDA investigators observed continued insanitary conditions and numerous serious violations of current good manufacturing practices (CGMP) at Herbal Doctor Remedies’ facility. On March 23, FDA recommended Herbal Doctor Remedies recall all unexpired drugs, and the company agreed. FDA encourages Health care professionals and patients to report adverse events or quality problems experienced with the use of any medication to FDA’s MedWatch Adverse Event Reporting program:  Complete and submit the report online; or Download and complete the form, then submit it via fax at 1-...

en Español [10/11/2019]  FDA advises consumers not to use Rompe Pecho EX and Rompe Pecho CF cough syrups distributed by Efficient Laboratories, Inc., Miami, Florida, due to microbial contamination risks. These are over-the-counter medicines for children six years and older. FDA recommends consumers stop using these medicines and dispose of them. These contaminated cough medicines could potentially cause illness. On October 9, 2019, FDA recommended that Efficient Laboratories recall Rompe Pecho EX and Rompe Pecho CF cough syrups. To date, the company has not taken action to remove these potentially dangerous medicines from the market. FDA is not aware of any reports of adverse events associated with these medicines at this time. Consumers who use Rompe Pecho EX and Rompe Pecho CF cough syrups and have concern...

Spanish version Update [6/29/2020] FDA is alerting consumers of Saniderm Products and UVT Inc.’s voluntary recall of Saniderm Advanced Hand Sanitizer. Following FDA’s recommendation, two distributors – Saniderm Products and UVT – agreed to recall Saniderm Advanced Hand Sanitizer packaged in 1-liter plastic bottles and labeled with “Made in Mexico” and “Produced by: Eskbiochem SA de CV.” The UVT hand sanitizer is labeled with lot number 0530 and an expiration date of 04/2022. The Saniderm Products hand sanitizer is labeled with lot number 53131626 and “Manufactured on April/1/20.” [6/19/2020] FDA advises consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood alcohol), a substance that can be toxic when absorbed through the skin or in...

Update [8/19/2020] FDA is alerting consumers and health care professionals to Maison Terre’s voluntary recall of all lots of its organic goldenseal root powder. The recalled goldenseal root powder was distributed nationwide to customers who ordered through Amazon.com between Jan. 25, 2015 and Aug. 4, 2020. FDA is also aware the goldenseal root powder was available on www.maisonterre.net. [8/14/2020]  FDA advises consumers and Health care professionals not to use goldenseal root powder repackaged and distributed by Maison Terre, Little Rock, Arkansas, due to microbial contamination. FDA laboratory analysis found the product is contaminated with high counts of various bacteria, including multiple pathogens. Use of these contaminated products can cause serious infections with severe outcomes, including death, esp...

Update [3/25/2021]  FDA is alerting health care professionals of BD’s voluntary recall expansion of ChloraPrep 3 mL applicators to include all U.S. states.  [3/19/2021] FDA advises Health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company), due to microbial contamination risks. The drug was distributed globally and is labeled with “CareFusion, El Paso, TX.” BD’s investigation confirmed the product’s lid, when exposed to higher temperature and humidity, can fail and lead to microbial contamination which may cause serious infections, especially in patients with compromised immune systems. This drug is used to sanitize skin prior to surgery or catheter procedures. Health care professionals should use an available alternative. FDA recommended on March 15,...