Class II · Moderate risk
Alcolado Relampago
CGMP DEVIATIONS
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
Fentanyl 1
Subpotent Drug
Class II · Moderate risk
Clear Eyes
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Class II · Moderate risk
NaturalCare
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
NaturalCare bioAllers
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
NatraBio
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
NaturalCare bioAllers
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
Carbidopa and Levodopa Tablets
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Class II · Moderate risk
Sterile Water for Injection
CGMP Deviations: Potential product carryover.
Class II · Moderate risk
Metformin hydrochloride Extended-Release Tablets
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Phenylephrine HCl in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Diltiazem HCl in 0.7% Sodium Chloride Injection
Lack of Assurance of Sterility
Class III · Low risk
Evamist (estradiol transdermal spray)
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Class II · Moderate risk
Phenylephrine HCl 20 mg
CGMP DEVIATIONS
Class II · Moderate risk
Phenylephrine HCl 40 mg
CGMP DEVIATIONS
Class II · Moderate risk
Phenylephrine HCl 1mg per 10mL
CGMP DEVIATIONS
Class II · Moderate risk
Phenylephrine HCl 0.5 mg per 5 mL
CGMP DEVIATIONS
Class III · Low risk
Dibucaine 1% Hemorrhoidal Ointment
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Gabapentin Tablets
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.