Class II · Moderate risk
Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class II · Moderate risk
Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
Class III · Low risk
Atorvastatin Calcium tablets
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
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 III · Low risk
Levofloxacin Injection in 5% Dextrose
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class III · Low risk
Levofloxacin Injection in 5% Dextrose
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class III · Low risk
Levofloxacin Injection in 5% Dextrose
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
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 III · Low risk
Moxifloxacin Ophthalmic Solution USP
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Class III · Low risk
Testosterone 200 mg Pellet
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label
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.
Class II · Moderate risk
P/P/P (Prostaglandin/Papaverine/Phentolamine)
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Acetylcysteine 10% Oph Solution
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Medroxprogesterone 1% Ophthalmic Solution
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.