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FDA lab findings again link Rugby Diocto oral liquid docusate sodium to B. cepacia infections Update [10/27/2017] FDA testing has identified Burkholderia cepacia in several bottles of Rugby Diocto (docusate sodium) oral liquid from lot No. 20351701 manufactured by PharmaTech LLC, Davie, Florida. This lot was collected by FDA in response to a 2017 multistate outbreak of B. cepacia complex (BCC) bacterial infections that has affected at least eight patients in California and Maryland. Laboratory evidence from FDA and CDC indicates that PharmaTech’s docusate sodium product is the source of the BCC infections. An outbreak in 2016 included serious infections in 63 confirmed cases and 45 suspected cases in 12 states. These 2016 infections were also linked to contaminated product made by PharmaTech, as confirmed by CDC and...

FDA lab confirmed high levels of microbial contamination in company’s Pasta De Lassar Andromaco diaper rash treatment En Español [3/30/2018] The U.S. Food and Drug Administration is alerting consumers of a voluntary recall of a topical drug product Pasta De Lassar Andromaco zinc oxide diaper rash treatment, made by Industria Farmacéutica Andrómaco, Toluca, Mexico, and distributed by MarcasUSA LLC, El Segundo, California. FDA laboratory analysis confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. This is especially concerning because Pasta De Lassar Adromoca is labeled for use to relieve diaper rash, where irritated skin can become infected. Therefore, consumers and caregivers should not use this product due to possible microbial contamination that may cause infection...

[10/11/2018] The Food and Drug Administration is alerting consumers about a voluntary recall of all lots with expiration dates from October 2018 to July 2022 of Sprayology’s water-based homeopathic product line for human use. These products are labeled as a homeopathic and are being recall ed due to microbial contamination at the King Bio Inc. manufacturing facility in Asheville, North Carolina. Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention. Previously, FDA alerted consumers to four other voluntary recall s related to King Bio’s recall : Health care professionals and patients should report any adverse events associated with Sprayology's products to the FDA’s MedWatch Adverse Event Reporting pr...

Update [2/22/2023] FDA recommended that Global Pharma recall Delsam Pharma’s Artificial Eye Ointment, and the firm agreed to initiate a recall. Update [2/21/2023] In addition to Artificial Tears products, FDA is also now warning consumers and Health care professionals not to purchase or use Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination . This is an over-the-counter product, manufactured by Global Pharma Health care Private Limited, intended to be sterile. En Español [2/2/2023] FDA is warning consumers and health care practitioners not to purchase and to immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. Using contaminated artificial tears increases risk of eye infections that could result in blindne...