Class II · Moderate risk Terminated
Zolpidem Tartrate Tablets
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Extended Phenytoin Sodium Capsules
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Lamotrigine Extended-Release Tablets
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Lisinopril Tablets USP
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Nitrofurantoin Monohydrate/Macrocrystals Capsules
Reason Failed Dissolution Specification; 6 month time point
Class II · Moderate risk Terminated
Nifedipine Extended-Release Tablets
Reason Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Class II · Moderate risk Terminated
Well at Walgreens Regular Strength Antacid Liquid
Reason Products failed the Antimicrobial Effectiveness Test.
Class II · Moderate risk Terminated
Well at Walgreens Regular Strength Comfort Gel Cherry Flavor
Reason Products failed the Antimicrobial Effectiveness Test
Class II · Moderate risk Terminated
Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ
Reason Products failed the Antimicrobial Effectiveness Test
Class II · Moderate risk Terminated
Mucinex Fast Max DM Max
Reason Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class II · Moderate risk Terminated
Ketorolac Tromethamine Inj. USP
Reason Crystallization
Class II · Moderate risk Terminated
Ketorolac Tromethamine Inj. USP
Reason Crystallization
Class II · Moderate risk Terminated
Fluoxetine Capsules USP
Reason Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Class II · Moderate risk Terminated
Fluoxetine Capsules USP
Reason Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Class II · Moderate risk Terminated
Hydroxyzine Hydrochloride
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Hydroxyzine Hydrochloride
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Class II · Moderate risk Terminated
C-Topical 4% CII
Reason Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL
Class II · Moderate risk Terminated
GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; increased complaints received for leaks
Class II · Moderate risk Terminated
Clinimix E 5/20 sulfite-free
Reason Lack of Assurance of Sterility; increased complaints received for leaks
Class II · Moderate risk Terminated
5% Dextrose Injection
Reason Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Class II · Moderate risk Terminated
Hydroxocobalamin 1) 1000mcg/mL
Reason Lack of assurance of sterility