Drug recall D-0409-2019
Product
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09
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
331B18009
Recall details
- Recalling firm
- Prinston Pharmaceutical Inc, Somerset, NJ
- Quantity
- 19800 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 18, 2019
Related products
- Irbesartan – drug information
- NDC 43547-374 Irbesartan · Irbesartan 75 mg/1 · Solco Healthcare U.S., LLC
- NDC 43547-375 Irbesartan · Irbesartan 150 mg/1 · Solco Healthcare U.S., LLC
- NDC 43547-376 Irbesartan · Irbesartan 300 mg/1 · Solco Healthcare U.S., LLC