Home / Recalls / Northwind Pharmaceuticals LLC / D-1095-2018

D-1095-2018 Class II Terminated

Recalled by Northwind Pharmaceuticals LLC — Indianapolis, IN

Recall Details

Product Type
Drugs
Report Date
August 22, 2018
Initiation Date
July 18, 2018
Termination Date
March 25, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
68 bottles

Product Description

Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52

Reason for Recall

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

Distribution Pattern

Indiana

Code Information

Lot: UT48320002, exp 07/31/2018; Lot UT48320003, exp 05/31/2019

Other recalls by Northwind Pharmaceuticals LLC

  • D-0654-2025 Class II — Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength pac (August 20, 2025)
  • D-0549-2023 Class II — BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackag (March 16, 2023)
  • D-0552-2023 Class II — Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52) (March 16, 2023)
  • D-0548-2023 Class II — Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged (March 16, 2023)
  • D-0550-2023 Class II — Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind (March 16, 2023)
  • D-0551-2023 Class II — Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52) (March 16, 2023)
  • D-0554-2023 Class II — Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind (March 16, 2023)
  • D-0553-2023 Class II — Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), (March 16, 2023)
  • D-1097-2018 Class II — Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharma (July 18, 2018)
  • D-1096-2018 Class II — Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: North (July 18, 2018)