Class II · Moderate risk Terminated
Arzol
Reason cGMP deviations: Temperature abuse
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Class II · Moderate risk Terminated
Olanzapine single dose vial Lyophilized
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Lidocaine Patch
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Bupivacaine HCl Injection
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Bupivacaine HCl Injection
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Bupivacaine HCl Injection
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Bupivacaine HCl Injection
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Bupivacaine HCl Injection
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Azithromycin for Injection USP Vial
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Topex
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
TobraDex
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Miocol-E
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Epi-Pen 2-Pak
Reason cGMP deviations: Temperature abuse
Class I · High risk Terminated
Insulin Glargine
Reason Labeling: Missing label on the vial
Class III · Low risk Terminated
Cyanocobalamin Injection
Reason Subpotent Drug: Out of specification for assay.
Class II · Moderate risk Terminated
Losartan Potassium Tab. USP 50mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk Terminated
Pantoprazole Sodium Delayed-Release Tablets
Reason CGMP deviations: tablets cracking
Class II · Moderate risk Terminated
Rifampin for Injection
Reason Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Class II · Moderate risk Terminated
Losartan Potassium 50 mg Tablet
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk Completed
Trulicity
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Class II · Moderate risk Completed
Trulicity
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class I · High risk Completed
Humalog KwikPen
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class II · Moderate risk Terminated
Kill 'Dat Sanitizing Products Hand Sanitizer
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Class II · Moderate risk Terminated
Sermorelin Acetate 1 mg/mL
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.