Class II · Moderate risk
Rhinall (phenylephrine hydrochloride)
CGMP Deviations: products manufactured under conditions that could impact its product quality.
FDA Drug Recalls
982 recalls · Class II, newest first
Class II · Moderate risk
DERMATONE (titanium oxide 6% and zinc oxide 4.7%)
Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
Class II · Moderate risk
Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach
Lack of assurance of sterility.
Class II · Moderate risk
Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach
Lack of assurance of sterility.
Class II · Moderate risk
Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach
Lack of assurance of sterility.
Class II · Moderate risk
Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
Class II · Moderate risk
Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
Class II · Moderate risk
Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
Class II · Moderate risk
Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
Class II · Moderate risk
Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
Class II · Moderate risk
Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specifications: Out of specification result for the dissolution test.
Class II · Moderate risk
Lidocaine 2.5% and Prilocaine Cream
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
Valsartan/HCTZ 320/25mg Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan/HCTZ 160/25mg Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan/HCTZ 160/12.5 mg Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Valsartan 320 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan 320 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan 80 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan tablets 160 mg
Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Papav 300/Phent 5mg/10mL
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
P/P/P 0.02/40/2mg/mL
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PRO/PA/PH/AT 18mcg/1.8mg/
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PRASH 12.2mcg/1.22m/19.29
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.