Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
FDA Drug Recalls
1,464 recalls · Class II, newest first
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Famotodine Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Clarithromycin Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Zolpidem Tartrate Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lamotrigine Extended-Release Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Amlodipine Besylate Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Nitrofurantoin Monohydrate/Macrocrystals Capsules
Failed Dissolution Specification; 6 month time point
Class II · Moderate risk
Nifedipine Extended-Release Tablets
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Class II · Moderate risk
Well at Walgreens Regular Strength Antacid Liquid
Products failed the Antimicrobial Effectiveness Test.
Class II · Moderate risk
Well at Walgreens Regular Strength Comfort Gel Cherry Flavor
Products failed the Antimicrobial Effectiveness Test
Class II · Moderate risk
Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ
Products failed the Antimicrobial Effectiveness Test
Class II · Moderate risk
Mucinex Fast Max DM Max
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
Ketorolac Tromethamine Inj. USP
Crystallization
Class II · Moderate risk
Ketorolac Tromethamine Inj. USP
Crystallization
Class II · Moderate risk
Fluoxetine Capsules USP
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
Fluoxetine Capsules USP
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
Hydroxyzine Hydrochloride
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Hydroxyzine Hydrochloride
Failed Impurities/Degradation Specifications
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Class II · Moderate risk
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Class II · Moderate risk
C-Topical 4% CII
Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL