Drug recall D-0412-2019
Product
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 90 count NDC 43547-331-09
Reason for recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Lots and codes
327B18008 327B18009
Recall details
- Recalling firm
- Prinston Pharmaceutical Inc, Somerset, NJ
- Quantity
- 12294 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 18, 2019
Related products
- Irbesartan and Hydrochlorothiazide – drug information
- NDC 43547-331 Irbesartan and Hydrochlorothiazide · Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1 · Solco Healthcare US, LLC
- NDC 43547-330 Irbesartan and Hydrochlorothiazide · Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 · Solco Healthcare US, LLC