Qualitest Pharmaceuticals Issues a Nationwide Recall of All Accusure® Insulin Syringes

Qualitest Pharmaceuticals today issued a voluntary nationwide recall of all Accusure® Insulin Syringes. The distributed syringes are of the following descriptions and NDC numbers: 28G 1/2cc, NDC 0603-6995-21;28G 1cc, NDC 0603-6996-21; 29G 1/2cc NDC 0603-6997-21, 29G 1cc, NDC 0603-6998-21, 30G 1/2cc, NDC 0603-999-21, 30G 1cc, NDC 0603-7000-21, 31G 1/2cc, NDC 0603-7001-21; and 31G 1cc, NDC 0603-7002-21. All Accusure® Insulin Syringes regardless of lot number are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe.

If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection.

Consumers who have any Accusure® Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. You can find the lot number on the white paper backing of each individual syringe.

Qualitest is notifying all customers who received these syringes and arranging for the return of any affected product.

The recall is being made with the knowledge of the Food and Drug Administration.

Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either on line, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/medwatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178

American Regent Voluntarily Recalls All Lots of Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials

American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 30 mg/mL:

• NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial
• NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL)

This voluntary recall is due to the potential that particulate matter in conjunction with crystallization may be present in the product. This recall does not include other concentrations of AMERICAN REGENT Ketorolac Tromethamine Injection, USP. American Regent is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients, including obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.

The product was distributed to wholesalers and distributors nationwide and to one account in Abu Dhabi.

Hospitals, surgi-centers, clinics and other healthcare facilities should not use any AMERICAN REGENT Ketorolac Tromethamine Injection, USP Injection 30 mg/mL for patient care and should immediately quarantine any product for return.

“Patient safety is our primary concern, and we are committed to taking the necessary steps to protect patients from any potential safety risks,” said Mary Jane Helenek, President and CEO of American Regent.

On Friday, October 16, 2009, American Regent voluntarily recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization. This recall does not affect the other strength of Ketorolac Tromethamine Injection, USP, 15mg/mL, 1 mL Single Dose Vial, NDC # 0517-0601-25.

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the Agency.

As is standard practice, and as stated in the Ketorolac Tromethamine Injection Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.”

American Regent will credit accounts for all returned Ketorolac Tromethamine Injection, USP product. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30 AM to 7:00 PM ET.

Hospitals, surgi-centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 631-924-4000.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. via email at PV@luitpold.com, by fax to 610-650-7781 or 610-650-0170 or by phone at 1-800-734-9236. Adverse reactions may also be reported to FDA’s MedWatch Adverse Event Reporting program online, by phone [1-800-FDA-1088], or by returning the postage paid FDA form 3500, by mail to [MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or via fax [1-800-FDA-0178].

Ketorolac Tromethamine Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR). The recall only impacts MPRs manufactured from July 2002 – March 2008 and matching the lot numbers listed on the following Unomedical web page: Unomedical MPR Recall. This recall is being conducted because of a potential malfunction of certain units of the MPR, which may impair the ability of the device to generate the positive pressure necessary to function properly. The occurrence of such a malfunction may create a situation in which the use of the product could potentially cause serious adverse health consequences or death. This recall does not impact any MPRs manufactured after March 2008.

Unomedical is contacting customers to arrange for the return and credit of all MPR units subject to this recall by sending notification letters to distributors and customers. In addition, the company has set up a web page with a list of affected lot numbers, guidance (diagram and photos) to allow customers to identify products subject to the recall in the event that the customer has already removed the primary product packaging, and instructions on what actions to take.

In order to distinguish between the recalled product and unaffected product, customers may examine the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned to Unomedical as instructed. MPR units with a clearly visible blue retention ring are not affected and do not need to be returned.

The MPR is a single-patient use device used by healthcare professionals. It is intended for patients requiring total or intermittent ventilatory support.

Unomedical notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the product on October 1, 2009.

Customers with questions are urged to contact Unomedical at 1-800-634-6003. Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF- 2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at: www.fda.gov/medwatch.

New USP Standards for Heparin Products Will Result in Decreased Potency
Adjustments may be Needed to Achieve Desired Anticoagulant Effect in Some Patients
New Heparin to Ship Starting October 8

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common anti-clotting drug.

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.

Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.

Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.

Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.

Prescription and over–the–counter medicines available in the United States must generally meet USP’s public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.

The monograph was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.

Philips announced today that it is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable. Only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) manufactured between May, 2007 and January, 2008 are included in the voluntary recall.

The HeartStart FR2+ defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest. The device automatically analyzes the heart rhythm and determines whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy.

Philips has received reports of a memory chip failure in a small number of FR2+ units manufactured in 2007 and early 2008. These reported failures were detected during routine self tests, not during emergency use of the AED. Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated, although Philips has received no reports of injury associated with this chip failure.

The AEDs affected by this recall have been distributed globally to fire departments, emergency medical services, hospitals, and other organizations. Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs by sending notification letters to distributors and users. In addition, the company has set up a page on the Philips Web site with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is. The webpage is: www.philips.com/FR2PlusAction.

Philips has notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the affected product. Customers who have questions about the recall or wish to report product problems may contact HeartStart Customer Service at 1-800-263-3342.

Any adverse events experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at: www.fda.gov/medwatch.

FDA Warns Consumers Not to Use Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution

The U.S. Food and Drug Administration today advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.

The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.

Dey issued an advisory on Sept. 11, 2009 regarding the theft. Although the FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, 2009 are from one of the following lots:

Albuterol Sulfate Inhalation Solution (892,000 doses; all lots contain 3.0 ml vials and display the brand name “Dey”)

• Lot number 9G04, NDC # 49502-697-29
• Lot number 9FD8, NDC # 49502-697-61
• Lot number 9FD9, NDC # 49502-697-61
• Lot number 9FE1, NDC # 49502-697-61

Ipratropium Bromide Inhalation Solution (432,000 doses; all lots contain 2.5 ml vials and display the brand name “Dey”)

• Lot number F09089, NDC # 49502-685-31
• Lot number C09119, NDC # 49502-685-62
• Lot number C09120, NDC # 49502-685-62

Do not use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots and was purchased or received after Sept. 8, 2009. Replace it with the same product from another lot.

Notify your health care professional of any adverse effects you may have experienced as a result of taking these medications.

Bring products from these lots back to the pharmacy where you received the medicine to exchange for products from a different lot or call Dey customer service at 800-527-4278. Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.

Alli, a diet product by GSK used for reducing the amount of fat absorbed from food, is being investigated by the FDA due to reports of severe liver damage and liver failure in similar products as Alli. For more information about Alli and the possible Alli recall, please visit: FDA Alli Recall. Currently, Alli is only being investigated for possible liver damage.

FDA Issues Early Communication about Ongoing Safety Review of Orlistat.
Weight loss drug review includes both prescription drug Xenical and OTC drug Alli.

The U.S. Food and Drug Administration announced today that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical and the over-the-counter medication Alli.

Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDA’s Center for Drug Evaluation and Research Drug Safety Oversight Board.

“The issues here are complex, but FDA has benefited from the input of the Board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services,” said Steven Osborne, M.D., executive director of the Board.

The FDA’s analysis of these data is ongoing, and no definite association between liver injury and orlistat has been established at this time. Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.

For more information on the Early Communication about the ongoing safety review please read: Orlistat (Marketed as Alli and Xenical) Safety Review. The Early Communication is a risk communication tool used by the FDA to inform the public about its ongoing safety reviews of drugs. The FDA will release its findings on orlistat as soon as the review is completed.

Consumers who have used orlistat should consult a health care professional if they experience symptoms possibly associated with development of liver injury, particularly weakness or fatigue, fever, jaundice, or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.

The FDA urges both health care professionals and consumers to report suspected side effects from the use of orlistat to FDA’s MedWatch Adverse Event Reporting program.

FDA’s Early Communication about the Ongoing Safety Review of Orlistat.

FDA is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli.

Xenical (orlistat 120mg) was approved as a prescription product by FDA in 1999 for obesity management in conjunction with a reduced caloric diet, and to reduce the risk of regaining weight after prior weight loss. In 2007, Alli (orlistat 60mg) was approved for OTC use for weight loss in overweight adults, 18 years and older, in conjunction with a reduced-calorie and low-fat diet. Currently, orlistat is approved for marketing in approximately 100 countries. In January 2009, a nonprescription version of orlistat was approved for sale in the European Union.

Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA’s Adverse Event Reporting System. Thirty of the 32 reports occurred outside the United States. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalization was reported in 27 of the 32 cases.

In addition to the 32 reported cases, this issue was discussed at the CDER Drug Safety Oversight Board in April 2009, and FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat. FDA’s analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time.

FDA is not advising healthcare professionals to change their prescribing practices with orlistat. Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed.

Consumers should consult their health care professional if they are experiencing symptoms possibly associated with the use of orlistat and development of liver injury, particularly weakness or fatigue, fever, jaundice or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.

FDA urges both healthcare professionals and consumers to report side effects from the use of orlistat (Alli and Xenical) to FDA’s MedWatch Adverse Event Reporting program.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA will communicate its findings to the public as soon as its review of orlistat is complete.

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. The FDA will release an update when additional information or analyses become available.

People who use Reglan may be at risk to tardive dyskinesia. Recently published analyses suggest that Reglan, also known as metoclopramide, is the most common cause of drug-induced movement disorders. More than two million Americans use these products for the treatment of a number of gastrointestinal disorders depending on what form the physician prescribes the medication. The FDA has become aware of continued spontaneous reports of tardive dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more than three months.

To find out more, please visit: Tardive Dyskinesia Lawsuits.