Another Drug Company Recalls Tainted Sartan Products

Megan Brooks

January 21, 2019

Prinston Pharmaceutical Inc has recalled one consumer-level lot of irbesartan and seven lots of irbesartan hydrochlorothiazide (HCTZ) tablets because of the presence of the probable carcinogen N-nitrosodiethylamine (NDEA), marking the latest recall of tainted sartan products produced in the United States.

As with some other recent sartan recalls, this latest one, announced January 18, stems from the finding of NDEA in the active pharmaceutical ingredient (API) manufactured by China's Zhejiang Huahai Pharmaceuticals (ZHP), the company at the center of the tainted sartan crisis.

The recalled product was distributed nationwide to wholesale, distributor, repackager, and retail customers. It comes in 30- and 90-count bottles, with an expiration date of February 2021 for the one irbesartan lot and March 2021 for the seven irbesartan HCTZ lots.

Recalled Products
Product Lot Number
Irbesartan, 300 mg (90 count) 331B18009
Irbesartan HCTZ, 300 mg/12.5 mg (30 count) 327A18001
Irbesartan HCTZ, 300 mg/12.5 mg (30 count) 327A18002
Irbesartan HCTZ, 300 mg/12.5 mg (90 count) 327B18008
Irbesartan HCTZ, 300 mg/12.5 mg (90 count) 327B18009
Irbesartan HCTZ, 150 mg/12.5mg (30 count) 325D18004
Irbesartan HCTZ, 150 mg/12.5 mg (90 count) 325B18004
Irbesartan HCTZ, 150 mg /12.5 mg (30 count) 325D18005

To date, the company says it has not received any reports of adverse events related to this recall.

Prinston Pharmaceutical Inc, doing business as Solco Healthcare LLC, is notifying its distributors and customers by phone and in writing with a recall letter to stop distributing the recalled lots and to notify their subaccounts. The company is arranging for return of all recalled products. Instructions for returning recalled products are provided in the recall letter.

Recalled product should be returned to: Eversana, Attn: Returns Department, C/O Solco Healthcare 4580 S. Mendenhall, Memphis, TN 38141. To request a return label, contact customer service by email.

Earlier this month, Aurobindo Pharma USA recalled 80 lots of medicines containing valsartan because of the presence of NDEA.

Contaminated sartan products first surfaced last summer, when N-nitrosodimethylamine (NDMA) was detected in some valsartan products manufactured by ZHP.

In late September, the FDA banned imports of APIs and of finished drug products produced by ZHP after an inspection of the company's Chuannan facility in Linhai uncovered numerous manufacturing and quality-control problems. ZHP is the subject of an FDA import alert. In mid-October, the European Medicines Agency (EMA) announced measures for increased oversight of substances produced by ZHP.

The problem is not limited to ZHP. It has now spread to several other companies, with subsequent recalls of tainted valsartan products.

Last November, Mylan Pharmaceuticals recalled 15 lots of medicines containing valsartan, and Sandoz Inc recalled one lot of losartan potassium HCTZ because of the presence of NDEA.

Also in November, the FDA alerted providers about certain lots of irbesartan from SciGen Pharmaceuticals, owing to the presence of NDMA.

The FDA and the EMA are continuing to investigate the presence of NDEA and NDMA in angiotensin II receptor blockers.

Adverse reactions or quality problems associated with the use of valsartan products should be reported to FDA's MedWatch Adverse Event Reporting Program.

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