Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan and Hydrochlorothiazide
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
FDA Drug Recalls
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Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan and Hydrochlorothiazide
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Admelog Solostar
Reason Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Class II · Moderate risk Ongoing
Ventolin HFA
Reason Defective Delivery System: Elevated number of units with out of specification results for leak rate
Class I · High risk Ongoing
Infant 25% DEXTROSE Injection
Reason Presence of Particulate Matter: human hair found within an internal sample syringe.
Class II · Moderate risk Ongoing
Ventolin HFA
Reason Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Class I · High risk Ongoing
EpiPen Jr. 2-Pak
Reason Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Class I · High risk Ongoing
EpiPen 2-Pak
Reason Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Class II · Moderate risk Ongoing
Double Hyaluronic 1000
Reason Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
Class III · Low risk Ongoing
Inova
Reason Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Class II · Moderate risk Ongoing
Vitamin D3 100
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ultra Slim Shot
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ultra Cocktail #2
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ultra Amino Energy Cocktail
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ultra Amino Blend
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TriMix
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TriMix
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TriMix
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TriMix
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TriMix
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TriMix
Reason Lack of Assurance of Sterility