[ad_1]
Prinston Pharmaceutical Inc. recalled a lot of consumer-grade irbesartan and seven batches of irbesartan hydrochlorothiazide tablets (HCTZ) due to the presence of the probable carcinogen N-nitrosodiethylamine (NDEA), scoring the latest reminder of contaminated sartan products manufactured in the United States. .
Like some other recent recalls on sartan, the latter, announced Jan. 18, stems from the discovery of NDEA in the active pharmaceutical ingredient (API) manufactured by Chinese Zhejiang Huahai Pharmaceuticals (ZHP), the company at the center of the crisis of contaminated sartan. .
The recalled product has been distributed nationwide to wholesale customers, distributors, repackers and retailers. It is available in bottles of 30 and 90 units, with an expiry date of February 2021 for the irbesartan lot and March 2021 for the seven batches of HCTZ of irbesartan.
| Recalled products | |
| Product | Batch number |
|---|---|
| Irbesartan 300 mg (90 units) | 331B18009 |
| Irbesartan HCTZ, 300 mg / 12.5 mg (30 units) | 327A18001 |
| Irbesartan HCTZ, 300 mg / 12.5 mg (30 units) | 327A18002 |
| Irbesartan HCTZ, 300 mg / 12.5 mg (90 units) | 327B18008 |
| Irbesartan HCTZ, 300 mg / 12.5 mg (90 units) | 327B18009 |
| Irbesartan HCTZ, 150 mg / 12.5 mg (30 units) | 325D18004 |
| Irbesartan HCTZ, 150 mg / 12.5 mg (90 units) | 325B18004 |
| Irbesartan HCTZ, 150 mg / 12.5 mg (30 units) | 325D18005 |
To date, the company has stated that it has received no reports of adverse events related to this recall.
Prinston Pharmaceutical Inc., operating as Solco Healthcare LLC, advises its distributors and customers by telephone and in writing with a reminder letter to stop distributing recalled lots and to notify their sub-accounts. The company organizes the return of all recalled products. Instructions for returning the recalled products are provided in the reminder letter.
The recalled products should be returned to: Eversana, for the attention of the Returns Department, C / O Solco Healthcare 4580 S. Mendenhall, Memphis, TN 38141. To request a return label, contact Customer Service via email .
Earlier this month, Aurobindo Pharma USA recalled 80 batches of drugs containing valsartan due to the presence of NDEA.
Contaminated sartan products appeared last summer, when N-nitrosodimethylamine (NDMA) was detected in some of the ZHP-produced valsartan products.
At the end of September, the FDA banned imports of pharmaceutically active ingredients and finished pharmaceutical products manufactured by ZHP after an inspection of the company's Chuannan facilities in Linhai, which revealed numerous manufacturing and control issues quality. ZHP is subject to an FDA import alert. In mid-October, the European Medicines Agency (EMA) announced measures to strengthen surveillance of substances produced by ZHP.
The problem is not limited to ZHP. It has now spread to several other companies, with subsequent recall of products containing contaminated valsartan.
Last November, Mylan Pharmaceuticals recalled 15 batches of drugs containing valsartan and Sandoz Inc. recalled a batch of losartan potbadium HCTZ due to the presence of NDEA.
Also in November, the FDA alerted suppliers to some lots of irbesartan from SciGen Pharmaceuticals, due to the presence of NDMA.
The FDA and EMA are continuing their research on the presence of NDEA and NDMA in angiotensin II receptor antagonists.
Adverse reactions or quality problems badociated with the use of valsartan should be reported to the FDA MedWatch Adverse Events Reporting Program.
[ad_2]
Source link
