Class II · Moderate risk
Solco Healthcare US Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Blood Pressure Medication Recalls
Recalls of ARBs, ACE inhibitors, beta blockers and other hypertension drugs - the class behind the large valsartan and losartan nitrosamine recalls.
549 recalls in this category, newest first.
Class II · Moderate risk
Solco Healthcare US Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Solco Healthcare US Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class III · Low risk
Triamterene and Hydrochlorothiazide Tablets
Subpotent Drug
Class III · Low risk
Enalapril Maleate
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class III · Low risk
Enalapril Maleate
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class III · Low risk
Enalapril Maleate
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class III · Low risk
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Class III · Low risk
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Maxzide-25
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Class II · Moderate risk
Amlodipine and Benazapril HCL Capsules
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Class II · Moderate risk
Amlodipine and Benazapril HCL Capsules
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
Class III · Low risk
Triamterene and Hydrochlorothiazide Tablets
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Class II · Moderate risk
Nifedipine USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Valsartan Tablets
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Class III · Low risk
ENALAPRIL MALEATE Tablets
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Class III · Low risk
Enalapril Maleate Tablets
Failed Stability Specifications
Class III · Low risk
Enalapril Maleate tablets
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Class III · Low risk
Amlodipine Besylate Tablet
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
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