Class II · Moderate risk Terminated
MIC+Methyl B12 injection Methionine Inositol…
Reason Lack of processing controls
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Class II · Moderate risk Terminated
Global Hand Sanitizer with moisturizer
Reason CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk Terminated
Global Hand Sanitizer with moisturizer
Reason CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk Terminated
Zyprexa Intramuscular
Reason cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Class II · Moderate risk Terminated
Xylocaine-MPF with Epinephrine 1:200
Reason Low out of specification results for epinephrine assay.
Class III · Low risk Terminated
Leukine
Reason FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Class I · High risk Ongoing
Limar Hand Sanitizer
Reason Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class III · Low risk Terminated
Erythromycin Topical Gel
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Erythromycin Topical Solution USP
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
QiYu Hand Sanitizer
Reason Subpotent
Class I · High risk Terminated
Prairie Wolf Distillery Alcohol Antiseptic 80%
Reason Hand sanitizer packaged in bottles that resemble beverage containers.
Class I · High risk Terminated
Topotecan Injection 4 mg/4mL
Reason Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
Class III · Low risk Terminated
B-Force
Reason Superpotent
Class II · Moderate risk Terminated
Acetaminophen 325 mg tablets
Reason cGMP deviations: Discolored acetaminophen
Class II · Moderate risk Terminated
Solifenacin Succinate Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Chantix
Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Class II · Moderate risk Ongoing
Chantix
Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Class II · Moderate risk Ongoing
Chantix
Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk Terminated
Xolair
Reason Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Class II · Moderate risk Terminated
QiYu Hand Sanitizer Gel
Reason Subpotent
Class III · Low risk Terminated
Phytonadione Tablets 5 mg
Reason Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Class III · Low risk Terminated
Ketamine HCl Injection Solution
Reason Labeling: Incorrect Exp. Date: Incorrect BUD.
Class III · Low risk Terminated
Phytonadione Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Mephyton
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities