The Japanese subsidiary of Pfizer Inc is recalling a drug for high blood pressure which was found to contain a carcinogenic substance in its active ingredient valsartan, the drugmaker said on Friday.
More than 763,000 tablets of the drug Amvalo, manufactured from April to July in Mylan Laboratories Limited in India, are the subject to the recall, Pfizer Japan Inc said in a statement, adding there were no reports of any damage to health.
“We will fully pay careful attention to our manufacturing and quality control to prevent a recurrence,” Pfizer Japan President Akihisa Harada said.
Mylan NV said in November it would recall certain batches of blood pressure medicine valsartan in the United States after they were found to contain a probable cancer-causing impurity.
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Chinese pharmaceutical ingredient manufacturer Zhejiang Huahai Pharmaceuticals also said in July it would recall valsartan from consumers in the United States after finding traces of a probable carcinogen.
Last year, the Japanese Health Ministry asked pharmaceutical firms to check whether any of their drugs using valsartan contained any carcinogenic impurities.
“We sincerely apologize for causing troubles and worries to all including those who engage in medical care. We will fully pay careful attention to our manufacturing and quality control to prevent a recurrence,” its president Akihisa Harada said. (Reporting by Takashi Umekawa Editing by Alexander Smith)
Other Pharmaceutical Company Recalls
Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.
Prinston is only recalling lots of Irbesartan-containing products that contain N- nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.
N-nitrosodiethylamine (NDEA) is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
To date, Prinston Pharmaceutical Inc. has not received any reports of adverse events related to this recall.
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Irbesartan and Irbesartan HCTZ are used to control high blood pressure and for the treatment of heart failure. Irbesartan in combination with amlodipine plus hydrochlorothiazide is used to control high blood pressure.
Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on Irbesartan should continue taking their medication until their pharmacist provides a replacement, or their doctor prescribes a different medication that treats the same condition as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.
The product subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details, and batch or lot number on the bottle containing these products.
Prinston advised patients to check with their doctor or pharmacist before they stop taking their medications. Discontinuing a recalled drug could cause more immediate harm than staying on the medication.
Prinston said the following irbesartan and irbesartan hydrochlorothiazide tablets have been recalled:
• Irbesartan, 300 mg, 90 count, lot number 331B18009, expires February 2021
• Irbesartan HCTZ, 300 mg/12.5 mg, 30 count, lot number 327A18001, expires March 2021
• Irbesartan HCTZ, 300 mg/12.5 mg, lot number 327A18002, expires March 2021
• Irbesartan HCTZ, 300 mg/12.5 mg, 90 count, lot number 327B18008, expires March 2021
• Irbesartan HCTZ, 300 mg/12.5 mg, 90 count, lot number 327B18009, expires March 2021
• Irbesartan HCTZ, 150 mg/12.5mg 30 count, lot number 325D18004, expires March 2021
• Irbesartan HCTZ, 150 mg/12.5 mg, 90 count, lot number 325B18004, expires March 2021
• Irbesartan HCTZ, 150 mg /12.5 mg, 30 count, lot number 325D18005 expires March 2021
Princeton’s Irbesartan and Irbesartan/HCTZ tablets were distributed nationwide to wholesale, distributor, repackager and retail customers. Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is arranging for return of all recalled products. Instructions for returning recalled products are given in the recall letter.
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.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.
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.
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).
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