Class II · Moderate risk Terminated
Valsartan/HCTZ 160/25mg Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Valsartan/HCTZ 160/12.5 mg Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Valsartan 320 mg tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan 320 mg tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan 80 mg tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan tablets 160 mg
Reason Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Papav 300/Phent 5mg/10mL
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
P/P/P 0.02/40/2mg/mL
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
PRO/PA/PH/AT 18mcg/1.8mg/
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
PRASH 12.2mcg/1.22m/19.29
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
P/P/P
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Acetylcysteine 10% Oph Solution
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Medroxprogesterone 1% Ophthalmic Solution
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Vitamin D3 Injection
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Dehydrated Alcohol Solution
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Morphine Sulf inhalation
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Pr/Pa/Ph
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Triple P
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Avastin 1.25 mg/0.05 mL prefilled syringe
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
DMSO 6.25% Opth Sol
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Atropine 0.01% Opth Solution
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+
Reason Microbial Contamination of a Non-Sterile Product
Class II · Moderate risk Terminated
Dymista
Reason Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Class II · Moderate risk Terminated
10 mg/mL Rocuronium Bromide
Reason CGMP deviations: Product was released while a hood certification discrepancy was being investigated.