Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East…
Reason Lack of assurance of sterility.
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Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East…
Reason Lack of assurance of sterility.
Class III · Low risk Terminated
Atorvastatin Calcium tablets
Reason 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 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 III · Low risk Terminated
Levofloxacin Injection in 5% Dextrose
Reason Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class III · Low risk Terminated
Levofloxacin Injection in 5% Dextrose
Reason Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class III · Low risk Terminated
Levofloxacin Injection in 5% Dextrose
Reason Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
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 III · Low risk Terminated
Moxifloxacin Ophthalmic Solution USP
Reason 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 Terminated
Testosterone 200 mg Pellet
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label
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.