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 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
Lot numbers, UPCs & expiration codes
327B18008 327B18009
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-0412-2019
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Jan 18, 2019
- FDA report date
- Feb 6, 2019
- Quantity
- 12294 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Prinston Pharmaceutical Inc
Original FDA data
Every field from FDA enforcement report D-0412-2019, 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
- 327B18008 327B18009
- Postal code
- 08873-4107
- Report date
- Feb 6, 2019
- Product type
- Drugs
- Recall number
- D-0412-2019
- Classification
- Class II
- Recalling firm
- Prinston Pharmaceutical Inc
- Product quantity
- 12294 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 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 18, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 27, 2019