Class II · Moderate risk Terminated
Rhinall
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Dermatone
Reason Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
Class II · Moderate risk Terminated
Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason Failed Dissolution Specifications: Out of specification result for the dissolution test.
Class II · Moderate risk Terminated
Lidocaine 2.5% and Prilocaine Cream
Reason Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
Class II · Moderate risk Terminated
Valsartan/HCTZ 320/25mg Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan/HCTZ 160/25mg Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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.