Class II · Moderate risk Terminated
Nose Better Gel
Reason CGMP DEVIATIONS
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Class II · Moderate risk Terminated
Soltice Quick-RUB
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Unguentine Original Ointment for Burns
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Vencedor medicated balm
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Alcolado Relampago
Reason CGMP DEVIATIONS
Class III · Low risk Terminated
Fentanyl 1
Reason Subpotent Drug
Class II · Moderate risk Terminated
Clear Eyes
Reason Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Class II · Moderate risk Terminated
Carbidopa and Levodopa Tablets
Reason Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Class II · Moderate risk Terminated
Sterile Water for Injection
Reason CGMP Deviations: Potential product carryover.
Class II · Moderate risk Terminated
Metformin hydrochloride Extended-Release Tablets
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated
Phenylephrine HCl in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Diltiazem HCl in 0.7% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl 20 mg
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Phenylephrine HCl 40 mg
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Phenylephrine HCl 1mg per 10mL
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Phenylephrine HCl 0.5 mg per 5 mL
Reason CGMP DEVIATIONS
Class III · Low risk Terminated
Dibucaine 1% Hemorrhoidal Ointment
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Gabapentin Tablets
Reason Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.