Infants’ TYLENOL Oral Suspension, 1 oz. Grape: Recall - Dosing System Complaints

AUDIENCE: Consumer, Pharmacy

ISSUE: McNeil Consumer Healthcare notified the public of a recall of seven lots (approximately 574,000 bottles) of Infants’ TYLENOL Oral Suspension, 1 oz. Grape. There were complaints from consumers who reported difficulty using the Infants’ TYLENOL SimpleMeasure dosing system. SimpleMeasure includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe.

BACKGROUND: Infants’ TYLENOL...

AUDIENCE: Comsumer, Dentist

ISSUE: FDA notified parents, caregivers, consumers, and dental care professionals about reports of serious injuries and potential hazards associated with the use of all models of the Spinbrush. These reports indicated that while turned on, the brush head has either “popped off” or broken 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. When the unexpected release of any part of the powered toothbrush occurs, there is a potential for serious injury. This risk is higher for unattended children or adults who may...

Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices

AUDIENCE: Oncology, Pharmacy, Patient

ISSUE: The FDA is warning healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, manufactured by Roche and does not contain the medicine's active ingredient, bevacizumab, which my have resulted in patients not receiving needed therapy. 19 medical practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as...

Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy: Class I Recall - Humidifier Lids Fail to Pop Off at the Intended Pressure

Special order patient kits were sold under the following brand names:

• Salter Labs
• AdvaCare
• Allcare Medical
• Memorial Home Services
• Therapy Support Inc.
• Mendo-Lake Home Respiratory Services
• MedAssurance Inc.
• Abundant Home Care

AUDIENCE: Home Care, Consumers

ISSUE: FDA notified healthcare professionals of a Class I recall of Salter Labs 7600 Bubble Humidifier. A manufacturing defect was discovered in certain lots of the 7600 Bubble Humidifiers, where the humidifier lids failed to...

RegenArouse: Recall - Undeclared Drug Ingredient

AUDIENCE: Consumer

ISSUE: Regeneca, Inc. notifed the public of a nationwide recall of RegenArouse, Lot Number 130100. FDA lab analysis confirmed the presence of Tadalafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making this product an unapproved new drug.

Use of this product may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these...

AUDIENCE: Consumer

ISSUE: Wholistic Herbs Inc. notified the public it is recalling all quantities of "Koff & Kold" spray with herbal extract and "Kold Sore" spray with liquid sea mineral. "Koff & Kold" spray with herbal extract is intended to be sprayed into the nose and throat for treatment of colds, flu, cough, stuffy nose, and sinus infection. "Kold Sore" spray with liquid sea mineral is intended to be sprayed into the eyes for the treatment of dry eye and pink eye. The product is also intended to be sprayed into the nose for sinus allergy by pollen, and onto the lips and genitals for the treatment of fever blisters, shingles and herpes simplex.

These products...

Hand-held Dental X-Ray Units: FDA Safety Communication - Unreviewed Products May Not Be Safe or Effective

AUDIENCE: Dentistry

ISSUE: FDA notified healthcare professionals, including dentists, dental care professionals and veterinarians, about the illegal sale of hand-held dental X-ray units that have not been reviewed by the FDA. The FDA is aware of hand-held dental X-ray units being sold online by manufacturers outside the U.S. and directly shipped to customers in the U.S. These devices may not be safe or effective and could potentially expose the user and the patient to unnecessary and potentially harmful X-rays.

BACKGROUND: All hand-held dental X-ray units that have been certified by...