Why it was recalled
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.
Product description
Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-09
Lot numbers, UPCs & expiration codes
325B18004
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0410-2019
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Jan 18, 2019
- FDA report date
- Feb 6, 2019
- Quantity
- 2177 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Prinston Pharmaceutical Inc
Original FDA data
Every field from FDA enforcement report D-0410-2019, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 81910
- Address
- 700 Atrium Dr
- Code information
- 325B18004
- Postal code
- 08873-4107
- Report date
- Feb 6, 2019
- Product type
- Drugs
- Recall number
- D-0410-2019
- Classification
- Class II
- Recalling firm
- Prinston Pharmaceutical Inc
- Product quantity
- 2177 bottles
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-09
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 18, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 27, 2019