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 is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer. The product was distributed nationwide in the United States.

RECOMMENDATION: If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product. See the Press Release for lot number and UPC codes of affected product. Consumers can visit www.tylenol.com for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the press release and product photo, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm292566.htm

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 Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products. 

BACKGROUND: Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. Roche is the company that manufactures Avastin approved for marketing outside of the United States. Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:

• are labeled with Roche as the manufacturer
• display batch numbers that start with B6010, B6011 or B86017  

The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials. FDA approved versions of these medicines are available in adequate supply to meet demand.

RECOMMENDATION: Medical practices that have obtained products from Volunteer Distribution and QSP should stop using them and contact the FDA. These products should be retained and securely stored. To report suspect counterfeit products and other suspect products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions:

• Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989,
• Visit OCI’s Web site (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or
• Email – DrugSupplyChainIntegrity@fda.hhs.gov

Healthcare professionals and patients are encouraged to report adverse events related to the use of suspect injectable cancer medications to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the FDA Counterfeit Statement, letters to medical practices, and the company Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291968.htm

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 are not tested properly to assure their safety. 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.

The recall was the result of a routine FDA inspection which identified several labeling issues. 

BACKGROUND: “Koff & Kold” and “Kold Sore” were distributed throughout the Unites States to retail stores located in Texas, California, Washington, Virginia, New Jersey, New York, Maryland, Illinois, Georgia, Nevada, Arizona, North Carolina, South Carolina, and Florida. The products were also distributed through acupuncture clinics and the firm’s website at www.naturalapothecary.com. These two spray products were distributed from March 2009 through February 2012.

RECOMMENDATION: Consumers who have purchased “Koff & Kold” and “Kold Sore” are urged to discontinue use of the product and return the product to the place of purchase for a full refund. Consumers with questions may contact the company Monday through Friday 9:00am to 5:00pm CST at 214-691-3210.

Read the MedWatch safety alert, including a link to the firms Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291534.htm

AUDIENCE: Infectious Disease, Pharmacy

ISSUE: FDA notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis (boceprevir) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together.

A drug interaction study showed that taking boceprevir (Victrelis) with ritonavir (Norvir) in combination with atazanavir (Reyataz) or darunavir (Prezista), or with Kaletra (lopinavir/ritonavir) reduced the blood levels of the HIV medicines and boceprevir in the body (see Data Summary below). FDA will be updating the Victrelis drug label to include information about these drug interactions.

BACKGROUND: Victrelis is a hepatitis C virus (HCV) protease inhibitor used with the medicines peginterferon alfa and ribavirin to treat chronic (long-lasting) hepatitis C infection in adults. HIV protease inhibitors are a class of anti-viral drugs used to treat HIV infection. Ritonavir is an HIV protease inhibitor used to “boost” other HIV protease inhibitors, increasing their levels in the blood and making them more effective.

RECOMMENDATION: Patients should not stop taking any of their medicines without talking to their healthcare professional. Patients should contact their healthcare professional if they have any questions or concerns.

Healthcare professionals who have started patients infected with both chronic HCV and HIV on Victrelis and antiretroviral therapy containing a ritonavir-boosted protease inhibitor should closely monitor patients for HCV treatment response and for potential HCV and HIV virologic rebound. 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291144.htm

• AcipHex (rabeprazole sodium)
• Dexilant (dexlansoprazole)
• Nexium (esomeprazole magnesium) 
• Omeprazole (omeprazole) Over-the-Counter (OTC)
• Prevacid (lansoprazole) and OTC Prevacid 24hr
• Prilosec (omeprazole)  and OTC
• Protonix (pantoprazole sodium)
• Vimovo (esomeprazole magnesium and naproxen)
• Zegerid (omeprazole and Sodium bicarbonate) and OTC

AUDIENCE: Gastroenerology, Family Practice, Consumer

ISSUE: FDA notified the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve. The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels.

FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers. H2 receptor blockers are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and heartburn.

BACKGROUND: Proton pump inhibitors (PPIs) are marketed under various brand and generic drug names as prescription and over-the-counter (OTC) products. They work by reducing the amount of acid in the stomach. Prescription PPIs are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Over-the-counter PPIs are used to treat frequent heartburn.

Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea that does not improve. Symptoms include watery stool, abdominal pain, and fever, and patients may go on to develop more serious intestinal conditions. The disease can also be spread in hospitals.  

RECOMMENDATION: Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve. Information for Healthcare Professionals:

• A diagnosis of CDAD should be considered for PPI users with diarrhea that does not improve.
• Advise patients to seek immediate care from a healthcare professional if they experience watery stool that does not go away, abdominal pain, and fever while taking PPIs.
• Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm290838.htm

AUDIENCE: OB/GYN, Healthcare Professionals, Consumers

ISSUE: Pfizer Inc. notified healthcare professionals and consumers that it recalled 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic) for customers in the U.S. market. An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

BACKGROUND: These products are oral contraceptives indicated for the prevention of pregnancy. These products are packaged in blister packs containing 21 tablets of active ingredients and seven tablets of inert ingredients. Correct dosing of this product is important in avoiding the associated risks of an unplanned pregnancy.

RECOMMENDATION: Patients who have the affected product should notify their physician and return the product to the pharmacy. See the Press Release for a list of affected lot numbers.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm289803.htm

AUDIENCE: Pediatrics, Health Professionals, Consumers

ISSUE: Vitaflo USA has announced a voluntary recall of Renastart 14.11 oz (400g) cans, Batch Number 12832, because some of the product shipped throughout the United States during the period December 29, 2011 through January 26, 2012 was incorrectly labeled. Some immediate consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia). All other Vitaflo products, including Renastart cans in batches other than 12832 and Renastart packed in sachets, are not affected.

BACKGROUND: Renastart is a powdered medical food used in the dietary management of pediatric renal disease, for patients one year and older. Renastart 14.11oz (400g) product in cans is sold only in the United States. Following a customer complaint regarding the way the product was dissolving, Vitaflo determined that a small number of cans of a different product may have been wrongly labeled as Renastart. 

RECOMMENDATION: Vitaflo USA is urging anyone who has any Renastart 14.11 oz (400g) cans Batch Number 12832 to immediately stop using the product and to contact Vitaflo to arrange return of the product, at Vitaflo’s expense.  All patients who have consumed any Renastart from this batch should contact their health care professional immediately to determine next steps, including nutritional management alternatives.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm289705.htm

AUDIENCE: Risk Manager, Oncology, Pharmacy

ISSUE: Cephalon, Inc. notified healthcare professionals of a recall of Treanda (bendamustine HCL) for Injection 25mg/8mL, lot TB30111, expiration date 12/2012. This product lot is being recalled due to the presence of particulate matter found in a single vial, which has been identified as glass fragments. Potential adverse events after intravenous administration of solutions containing particulates may present as an emboli and result in disruption of blood flow causing tissue/organ damage, especially in vulnerable patients such as those undergoing surgery, immunosuppressed individuals, and the elderly, as well as patients with micro or macrovasular disease, such as cardiac and renal disease, who may be more at risk since their vasculature and end organs are already compromised.

The affected Treanda lot is packaged in 8 mL vials and was distributed to wholesalers and distributors nationwide between March 22, 2011 and October 5, 2011.

BACKGROUND: Treanda (bendamustine HCL) for Injection 25mg/8mL is indicated for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab-containing regimen.

RECOMMENDATION: Recipients of the subject lot have been previously notified of this recall via overnight notification on 11/18/11. Wholesalers, retailers, hospitals and health care professionals who have lot TB30111 in their possession are instructed to immediately cease using the product and immediately quarantine product for return.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm289521.htm

AUDIENCE: Neurology, Gastroenterology

ISSUE: FDA notified healthcare profesisonals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). PML is a rare but serious brain infection associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) or Crohn’s disease.

A patient’s anti-JCV antibody status may be determined using an anti-JCV antibody detection test that has been analytically and clinically validated, and has been ordered by a healthcare professional. The Stratify JCV Antibody ELISA test2 was cleared by FDA on January 20, 2012. Testing positive for anti-JCV antibodies means that a person has been exposed to JCV in the past.

BACKGROUND: Tysabri (natalizumab) is in a class of medications called immunomodulators. It works by stopping certain cells of the immune system from causing damage to the body. Tysabri is approved for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn’s disease since January 2008.

RECOMMENDATION: The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML. Patients with all three known risk factors have an estimated risk of PML of 11/1,000 users. See the Drug Safety Communication Data Summary section for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to tht eFDA Drug Safety Communication and News Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm288602.htm

• Men’s Minoxidil 15% Azelaic 5% Hair regrowth topical, 60ml
• Men’s Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL
• Men’s Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL
• Women’s Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL
• Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL

AUDIENCE: Consumer

ISSUE: Perfect Image Solutions recalled all lots of these topical hair regrowth products because they are deemed “unapproved new drugs” under FDA regulations, and may present potential health hazards.

Use of these topical products containing 15% and 10% Minoxidil have not been shown to be safe, and could pose a risk to the general public due to the possibility of systemic absorption. Skin abrasions or irritations, such as psoriasis or sunburn, could increase the systemic absorption of topically administered Minoxidil. Minoxidil 15% and 10% could cause low blood pressure, heart palpitations and associated cardiac symptoms. Azelaic acid contained in the topical products could make the skin where it is applied more sensitive to sunburn. Ketoconazole contained in the shampoo product could cause hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, rash, skin irritation and dry skin. Salicylic acid contained in the shampoo could cause mild, temporary burning, itching, irritation, or stinging.

BACKGROUND: These products are used to slow or stop hair loss and promote hair regrowth and are packaged in glass-dropper containers or plastic shampoo bottles, and are sold in single units. They are used by men and women generally in middle to late adulthood. The product can be identified by the name Perfect Image Solutions on the container. Product was distributed nationwide or worldwide via the internet.

RECOMMENDATION: Consumers that have product which is being recalled should discard it.

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm288562.htm