FDA Warnings
Latest FDA Updates
Healthy People Co. Dietary Supplements: Recall - Undeclared Drug Ingredient
UPDATED 02/22/2012. Recall expanded to include all lots purchased on or before October 25, 2011. Recalled products pose significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Infants’ TYLENOL Oral Suspension, 1 oz. Grape: Recall - Dosing System Complaints
Reports of dosing syringe flow restrictor being pushed into the bottle when inserting the syringe.
Spinbrush Powered Toothbrush by Arm and Hammer or Crest: Safety Communication - Choking Hazard and Serious Injuries
Brush head may break off in the user’s mouth or near the face, causing cuts to the mouth and gums, chipped or broken teeth, swallowing and choking on the broken pieces, and injuries to the face and eyes.
Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices
The counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy.
Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy: Class I Recall - Humidifier Lids Fail to Pop Off at the Intended Pressure
The humidifier can leak and can potentially interrupt the flow of supplemental oxygen to the patient.
RegenArouse: Recall - Undeclared Drug Ingredient
Product marketed as dietary supplement contains drug ingredient Tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
January 2012
Monthly Safety Labeling Changes includes 63 products with revisions to Prescribing Information.
Wholistic Herbs, Inc. "Koff and Kold" and "Kold Sore" Spray: Recall - Non-Sterile Products
Products intended for use in the eye that are non-sterile have the potential to cause eye infections, which may be sight threatening. Also, nasal solutions that are not sterile could lead to a respiratory infection.
Hand-held Dental X-Ray Units: FDA Safety Communication - Unreviewed Products May Not Be Safe or Effective
Products could potentially expose users and patients to unnecessary and potentially harmful X-rays.
Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication - Drug Interactions
Interactions between Victrelis and ritonavir-boosted atazanavir, lopinavir, and darunavir can potentially reduce the effectiveness of these medicines when co-administered.
FDA Articles on Unsafe Drugs Site
» Seroquel and FDA » FDA recalled Rezulin due to its link with Liver Failure » Study Links Tylenol (Acetaminophen) with Liver Damage » FDA recall of Children’s Motrin and Infant’s Motrin » FDA Safety Announcement for Tylenol » FDA’s role in the fight against Propecia Side Effects » FDA and Fen-Phen » Propulsid and FDA
