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Kedake Inc. Issues Allergy Alert on Undeclared Sesame, Soy, Wheat, Yellow No. 5, Yellow No. 6, and Red No. 6 in Botana Mix Snacks

KEDAKE, INC. of Houston, TX is recalling it’s 2 lb packages of Las Ollas Botana Mix Snacks because they may…

Compounding: Inspections, Recalls, and other Actions

Human drug compounding; FDA inspections; compounding recalls

Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)

A safety clinical trial shows a possible increased risk of cancer with the weight-loss drug Belviq, Belviq XR. Consider the…

FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems

FDA warns that untreated constipation caused by schizophrenia drug clozapine (Clozaril) can get worse and lead to serious bowel problems…

FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market

FDA has requested that the weight-loss drug Belviq, Belviq XR be withdrawn from the U.S. market because a safety clinical…

Is cross-border e-commerce air cargo demand at risk?

The looming demise of the de minimis exemption could spur higher costs and delays, said Xeneta’s Niall van de Wouw.

FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis

FDA requires a Boxed Warning about serious mental health side effects for the asthma & allergy drug Singulair (montelukast). Only…

FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems

FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due…

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid

FDA warns that NSAID use at 20 weeks or later in pregnancy may cause serious kidney problems in an unborn…

Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)

Preliminary safety trial results show an increased risk of serious heart-related problems and cancer with Xeljanz, Xeljanz XR (tofacitinib). FDA…