Back grey arrow rt.gif
 
 
FDA announces voluntary recall of several medicines
containing valsartan following detection of an impurity
 
 
  For Immediate Release
July 13, 2018
 
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm613532.htm
 
Release

 
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.
 
The FDA's review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.
 
"The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they're manufactured," said FDA Commissioner Scott Gottlieb, M.D. "When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we're committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients' therapeutic needs are met in the United States with an adequate supply of unaffected medications."
 
Information for Patients and Health Care Professionals
 
o Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.
 
o To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
 
o If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA's website.
 
o Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.
 
The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company. The supplier has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.
 

0717181

"We have carefully assessed the valsartan-containing medications sold in the United States, and we've found that the valsartan sold by these specific companies does not meet our safety standards. This is why we've asked these companies to take immediate action to protect patients," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.
 
The FDA will continue to investigate this issue and provide additional information when it becomes available. The agency encourages patients and health care professionals to report any adverse reaction to the FDA's MedWatch program.
 
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 
-------------------
 
https://www.fda.gov/Safety/Recalls/ucm613504.htm
 
Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products
 
For Immediate Release

July 13, 2018
Contact
Consumers

Solco Customer Service customerservice(at)solcohealthcare.com 1-866-931-9829
Announcement
 
Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer - Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product lots. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
 
The products are indicated for the treatment of hypertension.
 
Theexposureto the impurity N-nitrosodimethylamine (NDMA) that was detected in valsartan product line presents an unacceptable carcinogenic risk to the intended patient population. To date, Prinston Pharmaceutical Inc. has not received any reports of adverse events related to this recall.

0717182

The lot number and expiry date information can be found on the manufacturer's unit (see photographs below of packaged product bottle labels).
 
Retail pharmacies in possession of any unused products: Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-HCTZ Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg, within expiry dates from Jul 2018 to Jan 2020 should immediately return the product by following the instructions below:
 
o Please contact Solco Customer Service at 1-866-931-9829, Option 5, Monday through Friday (9am to 5pm EST) or email or fax to: customerservice@solcohealthcare.com; 1- 866-931-0709, for the Product Return.
 
o A call tag, a pre-printed, pre-paid return label will be provided to you for product return; return is free of charge.
 
o Return products to: DLSS (Dohmen Life Science Services) Attn: Returns Department 4580 S. Mendenhall, Memphis, TN 38141
 
Solco is notifying its distributors and customers by letter and email and is arranging for return of all recalled products. Pharmacies and wholesalers that received the impacted products will receive a letter as well as a copy of this press release with their recall notification information.
 
If you have any questions regarding this recall, please call 1-866-931-9829, Option 5, between the hours of 9:00 a.m. to 5:00 p.m. EST Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product. Additional information regarding this recall affected products' lots and expiry dates can be found at http://www.solcohealthcare.com/uploads/news/ValsartanHCTZRecallAffactedLots.pdf or to download at http://www.solcohealthcare.com/uploads/news/ValsartanHCTZRecallAffactedLots.xlsx Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.
 
o Complete and submit the report Online: www.fda.gov/medwatch/report.htm
o Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.
 
This Product Recall is being made with the knowledge of the United States Food and Drug Administration (FDA).
 
 
 
 
  iconpaperstack View Older Articles   Back to Top   www.natap.org