FDA Issued A Warning Letter To Valsartan API Manufacturer, Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP)

 Looks like not only iPhone and plastic toys are manufactured in China these days. Recently recalled Valsartan's active pharmaceutical ingredient too was manufactured in China by Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP). FDA is currently investigating probable cancer-causing impurities found in certain commonly prescribed heart medicines. FDA's letter to Zhejiang Huahai Pharmaceutical Co. Ltd. outlines several manufacturing violations at company’s Chuannan facility, including impurity control, change control and cross contamination from one manufacturing process line to another.

 

The U.S. Food and Drug Administration today released a warning letter issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang China, the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an ongoing FDA investigation into probable cancer-causing impurities in certain commonly prescribed heart medicines. The letter outlines several manufacturing violations at ZHP’s Chuannan facility, including impurity control, change control and cross contamination from one manufacturing process line to another. The warning letter is another step forward in the ongoing investigation. The agency is still looking into the root cause of the impurity.

“We’re continuing to investigate and take action to protect patient health and safety from products in this angiotensin II receptor blocker class that have been found to have dangerous impurities. As part of that investigation, we’ve uncovered serious manufacturing violations at ZHP, which is one of the manufacturing facilities that has been linked to these products. The issues cited in the warning letter are associated with the nitrosamine impurities found in these drugs, and these violations reveal a disturbing lack of oversight at this API manufacturer that puts patients at risk,” said FDA Commissioner Scott Gottlieb, M.D.

The ZHP facility manufactures API including valsartan, a drug in the angiotensin II receptor blocker (ARB) class used to treat high blood pressure and heart failure. On September 28, the FDA also put this facility on import alert, stopping all API made there and finished drug products made using its API from legally entering the U.S. The agency put ZHP on import alert based, in part, on high levels of impurities found in ZHP’s API.

The FDA announced recalls of valsartan beginning in July due to the presence of N-Nitrosodimethylamine (NDMA) in API supplied by ZHP. Subsequent international investigations expanded to include all manufacturers of API and finished drugs in the ARB class and have resulted in additional recalls of valsartan, irbesartan, and losartan-containing products found to contain NDMA and N-Nitrosodiethylamine (NDEA) – both known animal and suspected human carcinogens.  

There may be confusion regarding which products are affected by ARB recalls and which are not, especially concerning the most recent U.S. recalls of valsartan-containing products using API manufactured by Mylan that tested positive for unacceptable levels of NDEA. Certain ARB products have been recalled, and certain products that contain ARBs and one or more other active ingredients in a single dosage form have been recalled. It is important to note that the API in these products besides valsartan, irbesartan or losartan are not necessarily under a recall. As an example, valsartan/amlodipine/hydrochlorothiazide is one product that has been recalled. Neither amlodipine or hydrochlorothiazide are currently under recall. Similarly, losartan potassium and hydrochlorothiazide 100mg/25mg is a recalledproduct. The agency asks the public to pay careful attention to the agency’s website for the most accurate and up-to-date information. The agency’s website provides lists of valsartan products under recall, valsartan products not under recall and irbesartan products under recall for patients, health care providers and pharmacists to accurately confirm which products are affected.

The FDA continues to test all ARBs for the presence of impurities and has publicly posted two methods for manufacturers and regulatory agencies around the world to test their ARBs for the unexpected NDMA and NDEA impurities.

Patients taking any recalled ARB should continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option. It also is important to know that not all ARBs contain NDMA or NDEA, so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.

Patients, health care providers and pharmacists may contact the FDA’s Division of Drug Information for any questions regarding ARB recalls. Visit the FDA’s ARB recall webpage, call 855-543-3784 or email druginfo@fda.hhs.gov for more information. A question and answer webpage also provides information on these recalls.

Update And Request On Heparin Sodium Injection (Baxter)

[UPDATE 05/09/2008] FDA requested that health professionals and facilities review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all recalled heparin products have been removed and are no longer available for patient use. In addition, FDA informed health professionals about other types of medical devices that contain, or are coated with, heparin.

[UPDATE 04/29/2008] Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products.

[UPDATE 02/28/2008] Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions.

[Posted 02/11/2008] FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.

The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection.

Tags: FDA Recall, Drug recall, Heparin Recall, Baxter Recall

Report Links Baxter Heparin to More Deaths

NEW YORK (Associated Press) - A day after Baxter International Inc. recalled nearly all remaining batches of its blood thinner heparin, a report Friday linked the product to additional patient deaths.

Late Thursday, Baxter said it will recall all remaining lots of heparin single- and multi-dose injections and HEP-LOCK products. The company recalled nine production lots of heparin multi-dose injection in January after the drug was linked to four deaths and hundreds of allergic reactions.

On Friday, the New York Times reported that the Food and Drug Administration had discovered possible links to 17 other deaths. The paper added that the agency is focusing on a Chinese plant that supplies the active ingredient in heparin, which is made from mucous membranes extracted from pig intestines.

In a letter posted to the FDA Web site Thursday, the FDA discussed problems in the manufacturing process. It said some lots of heparin sold in the U.S. "included material from an unacceptable workshop vendor," among other issues.

While the FDA investigation is not complete, Goldman Sachs analyst Lawrence Keusch said there was reason to believe the problem was linked to the Chinese plant, Changzhou SPL.

"Baxter and the FDA have ruled out any issues at the company's Cherry Hill, New Jersey, finishing facility," he said. He added that the only form of Baxter's heparin left on the market is a premixed IV solution, which is not sourced from China.

Keusch said the expanded recall is not a surprise, and won't have much impact on Baxter.

"From a financial perspective, heparin sales were roughly $30 million in 2007, and with a gross margin of 20 percent are not material to earnings," he said.

He added the recall is unlikely to affect other Baxter product, because only a few of its minor products are processed in China, and none are made at the facility cited by the FDA.
tag: FDA Recall, drug recall, Changzhou SPL, heparin, HEP-LOCK products, Baxter International recall,

Merck & Co Recalls PedvaxHIB and COMVAX

Certain Lots of PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)]

COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]
NDC 0006-4897-00 and 0006-4898-00

DATE RECALL INITIATED:

December 11, 2007

PRODUCT / LOT NUMBER / EXPIRATION DATE:

PRODUCT DESCRIPTION	LOT #	EXP. DATE
PedvaxHIB®	0677U	11 January 2010
PedvaxHIB®	0820U	12 January 2010
PedvaxHIB®	0995U	16 January 2010
PedvaxHIB®	1164U	18 January 2010
PedvaxHIB®	0259U	17 October 2009
PedvaxHIB®	0435U	18 October 2009
PedvaxHIB®	0436U	19 October 2009
PedvaxHIB®	0437U	19 October 2009
PedvaxHIB®	0819U	09 January 2010
PedvaxHIB®	1167U	10 January 2010
COMVAX®	0376U	05 January 2010
COMVAX®	0377U	08 January 2010

MANUFACTURER:

Merck & Co., Inc.
West Point, PA

REASON:

These lots of PedvaxHIB and COMVAX are being recalled due to lack of assurance of product sterility.

Tags: PedvaxHIB recall, COMVAX recall, Merck & Co. recall

Bodee LLC, Inc. Recalls of All Encore Tablets, a Product Marketed as a Dietary Supplement

Contact:
Bodee LLC
(800) 935-0296




FOR IMMEDIATE RELEASE -- Century City, CA – November 21, 2007- Bodee LLC, 2222 Avenue of the Stars, 702E, Century City, CA 90067, announced today that it is conducting a voluntary nationwide recall of all the company's supplement product sold under the name Encore Tabs.

Bodee LLC is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Encore Tabs samples found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that one lot of Encore Tabs contains aminotadalafil, an analog of tadalafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains Aminotadalafil is close in structure to tadalafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses 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.

Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Encore Tabs is sold in health food stores, via the internet and by mail order nationwide and in Canada. The Encore Tabs product is sold as a 2-capsule blister pack packaged in a retail booklet with five booklets in a box.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The company advises that any unused portion be returned to Bodee LLC for a full purchase price refund by calling (800) 935-0296 for instructions on the return and refund process.

The Company is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Encore Tabs’ composition. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.

Tags: encore recall, encore, encore tablets, encore by bodee recall

FDA Requests Recall of 'True Man Sexual Energy,' 'Energy Max'

The U.S. Food and Drug Administration yesterday requested a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules, illegal drug products that contain potentially harmful, undeclared ingredients. The products, often advertised as ``all natural'' alternatives to approved erectile dysfunction drugs, could interact with medications and cause dangerously low blood pressure. They contain substances that have similar structures to active ingredients in approved prescription drugs.

The FDA has not approved True Man or Energy Max, and their safety and effectiveness are unknown.

The FDA requested the recall of all products distributed under both labels in a letter to Yin Kao, president and owner of America True Man Health Inc., of West Covina, Calif.

The products are often advertised in newspapers, retail stores, and on the Internet.

“The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure," said Janet Woodcock, M.D., deputy commissioner for scientific and medical programs, chief medical officer and acting director of the FDA’s Center for Drug Evaluation and Research.

As formulated, True Man Sexual Energy and Energy Max are classified as unapproved new drugs that do not declare the active ingredients thione, an analog of sildenafil; or piperadino vardenafil, an analog of vardenafil. Analogs may cause side effects and drug interactions similar to the approved drugs they resemble.

The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

The FDA issued an alert on May 10, 2007, (http://www.fda.gov/bbs/topics/NEWS/2007/NEW01633.html) advising consumers not to buy or use True Man or Energy Max products. Today’s recall request comes as a result of the company previously failing to notify all of their consignees and involves True Man Sexual Energy packaged in blister pack cartons of 10 capsules and Energy Max packaged in blister pack cartons of 20 capsules. FDA is prepared to take further regulatory action should the firm refuse to accede to this request.

FDA chemical analysis has shown that Energy Max contains thione, an analog of sildenafil, a substance similar to the active ingredient in the approved ED drug Viagra. In addition, FDA investigators found that True Man contains the same analog or an analog of vardenafil, the active ingredient Levitra, another approved ED treatment. Neither of the analogs used in True Man or Energy Max are components of FDA-approved drug products.

Customers who have either product in their possession should stop using it immediately and contact their health care provider if they have experienced any problems that may be related to taking this product.

Consumers should report adverse events related to these products to MedWatch, the FDA's voluntary reporting program:

www.fda.gov/medwatch/report.htm

Tags: FDA, Drug recall, True Man, Energy Max, illegal drug products, thione, piperadino vardenafil, diabetes, high blood pressure, high cholesterol

Infant Cold and caugh medicines recalled

I do not take over the counter medicines that most of the people are used to take. The advertisements on TV make it look like that you have to have cold medicines and the likes of Tylenol to get through the day. But I have not come to need of such things. I am able to continue with little discomfort through day to day life and cold bouts. I am against any child being given these kind of medicines. But I am not an expert, I just know what works for me. I do take my vitamins.
Here is a news post from New York Times;
WASHINGTON, Oct. 11 — Major makers of over-the-counter infant cough and cold medicines announced Thursday that they were withdrawing their products from the market for fear that they could be misused. (Really?)
The withdrawal comes two weeks after safety reviewers within the Food and Drug Administration urged the agency to consider an outright ban of over-the-counter cough and cold products for children under 6. Even the industry’s main trade group, the Consumer Healthcare Products Association, recommended two weeks ago that the products not be used in infants.
continued to sell cough and cold products labeled for infants. Last week, Representative Despite the recommendation, giant drug makers like Johnson & Johnson, Wyeth and NovartisHenry A. Waxman, the California Democrat who is chairman of the House Committee on Oversight and Government Reform, sent a letter to the industry’s trade association asking why the products were still being sold.

Tags: infant cough and cold medicines, Drug recall, Healthcare

Dietary supplement Zencore Tabs recalled

The maker of Zencore Tabs, marketed as a dietary supplement to enhance male sexual stamina, is recalling the product because it contains undeclared ingredients including aminotadalafil and sildenafil, chemicals whose derivatives are used in prescription medicines for erectile dysfunction, the U.S. Food and Drug Administration said Friday.
These and two other chemical ingredients, sulfosildenafil and sulfohomosildenafil, may interact with nitrates found in certain prescription drugs and could lower blood pressure to dangerous levels, the FDA said in a statement.
Zencore is marketed by Los Angeles-based Bodee LLC.
Consumers who have this product are urged to stop using it immediately and to see a health-care professional if they notice any side effects, the FDA said.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The company advises that any unused portion be returned to Bodee LLC for a full purchase price refund by calling (800) 935-0296 for instructions on the return and refund process.The Company is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Zencore Tabs’ composition. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.

Tags: Zencore Tabs, Zencore Tabs recall, aminotadalafil, sildenafil, erectile dysfunction, Bodee LLC, FDA, Medwatch