Home / Recalls / NuCare Pharmaceuticals Inc / D-1037-2018

D-1037-2018 Class II Terminated

Recalled by NuCare Pharmaceuticals Inc — Orange, CA

Recall Details

Product Type
Drugs
Report Date
August 15, 2018
Initiation Date
July 30, 2018
Termination Date
April 22, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9

Reason for Recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Distribution Pattern

Distributed to three customers in Fl and CA

Code Information

Lot # U01779; Exp. 04/30/2019

Other recalls by NuCare Pharmaceuticals Inc

  • D-1038-2018 Class II — Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharm (July 30, 2018)
  • D-1039-2018 Class II — Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharm (July 30, 2018)