Pharmacovigilance Russia (EAEU)

FDA MedWatch Drug Alerts

• Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination Апрель 19, 2018
  Audience: Consumer ISSUE: Viable Solutions of Nampa, ID has initiated a recall of certain Kratom-containing powder products, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal...
• NxtGen Botanicals Maeng Da Kratom by NGB Corp.: Recall - Possible Salmonella Contamination Апрель 19, 2018
  Audience: Consumer ISSUE: NGB Corp. of West Jordan, Utah is voluntarily recalling NxtGen Botanicals Maeng Da Kratom labeled bottles of encapsulated product because it has the potential to be contaminated with Salmonella, an organism which can cause...
• Euphoric Capsules by Epic Products: Recall - Undeclared Sildenafil and Tadalafil Апрель 18, 2018
  Audience: Consumer ISSUE: Overland Park, KS, Epic Products, LLC is voluntarily recalling all lots of Euphoric capsules, packaged in 1 count blister cards, 3 count bottles, and 12 count bottles to the consumer level. FDA analysis found samples of...
• Rhino 69 Extreme 50000 by AMA Wholesale: Recall - Presence of Tadalafil Апрель 18, 2018
  Audience: Consumer ISSUE: AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active...
• Coastal Meds to Recall All Products Marketed as Sterile Апрель 13, 2018
  Audience: Pharmacy, Nursing, Risk Manager ISSUE: FDA is alerting health care professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in some of the drug vials for...
• Sterile Injectable Products by Premier Pharmacy Labs: Recall - Lack of Sterility Assurance Апрель 12, 2018
  Audience: Pharmacy, Nursing  ISSUE: Premier Pharmacy Labs is voluntarily recalling injectable products due to a potential lack of sterility assurance. Microbial contamination was detected during routine testing of subsequent unreleased product...
• Maeng Da Red Powder and Capsules by Club 13: Recall - Possible Contamination With Salmonella Апрель 10, 2018
  Audience: Consumer ISSUE: Club 13 is recalling 15-gram, 30-gram, 90-gram, 150-gram, and 454-gram pouches, and all bulk orders of "Maeng Da Red" kratom powder, lot # MRMD012618 5-count, 25-count, 50-count, 100-count, 120-count capsule, and all...
• Essure Permanent Birth Control System by Bayer Healthcare: Announcement - FDA Restricts the Sale and Distribution Апрель 9, 2018
  Audience: OBGYN, Patient, Risk Manager ISSUE: The FDA is aware that some women have received the Essure device without being adequately informed of Essure’s risks. In order for this device to meet reasonable assurance of safety and effectiveness,...
• Kratom-containing Products by Triangle Pharmanaturals: Mandatory Recall - Risk of Salmonella Апрель 3, 2018
  Audience: Consumer ISSUE: FDA issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took...
• Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination Апрель 3, 2018
  Audience: Consumer ISSUE: NutriZone, LLC is recalling 4 different dietary supplements because it has the potential to be contaminated with Salmonella. The potential for contamination was noted after routine sampling and testing by the FDA revealed...