Northwind Pharmaceuticals recalls
FDA enforcement reports naming Northwind Pharmaceuticals LLC as the recalling firm.
- Recall reports
- 13
- Class I (serious)
- 0
- Most recent report
- Sep 24, 2025
- Sep 24, 2025Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged i…Drug · Northwind Pharmaceuticals LLCPresence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was d…Class II
- May 3, 2023Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharma…Drug · Northwind Pharmaceuticals LLCCGMP DeviationsClass II
- May 3, 2023BusPIRone Hydrochloride Tablets USP, 7Drug · Northwind Pharmaceuticals LLCCGMP DeviationsClass II
- May 3, 2023Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b…Drug · Northwind Pharmaceuticals LLCCGMP DeviationsClass II
- May 3, 2023Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b…Drug · Northwind Pharmaceuticals LLCCGMP DeviationsClass II
- May 3, 2023Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b)…Drug · Northwind Pharmaceuticals LLCCGMP DeviationsClass II
- May 3, 2023Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharma…Drug · Northwind Pharmaceuticals LLCCGMP DeviationsClass II
- May 3, 2023Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Nor…Drug · Northwind Pharmaceuticals LLCCGMP DeviationsClass II
- Aug 22, 2018Valsartan HCTZ, 160/12Drug · Northwind Pharmaceuticals LLCCGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.Class II
- Aug 22, 2018Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceutica…Drug · Northwind Pharmaceuticals LLCCGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.Class II
- Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceutic…
- Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuti…
- Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BO…
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