Class II · Moderate risk Ongoing
NaturalCare bioAllers
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
FDA Drug Recalls
17,898 recalls, newest first
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 III · Low risk Ongoing
Evamist
Reason 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 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.
Class III · Low risk Terminated
Buprenorphine Transdermal System
Reason Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Class III · Low risk Terminated
Buprenorphine Transdermal System
Reason Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Class II · Moderate risk Terminated
Warfarin Sodium Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Purely Soothing MSM Nasal Spray
Reason CGMP Deviations
Class I · High risk Ongoing
Purely Soothing 15% MSM Drops
Reason Non-Sterility