Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason Failed Dissolution Specifications: Out of specification for dissolution.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Levetiracetam Tablets
Reason Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Class II · Moderate risk Terminated
clomiPRAMINE Hydrochloride Capsules USP
Reason Failed Tablet/Capsule Specification
Class II · Moderate risk Terminated
Sodium Chloride Injection
Reason Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Class II · Moderate risk Terminated
Metformin HCl Extended Release Tablets USP 500 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated
Mesalamine Delayed-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Mesalamine Delayed-Release Tablets
Reason Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg
Reason Failed Dissolution Specification
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg
Reason Failed Dissolution Specification
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets
Reason Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Vapor Ointment packaged in a) 1/8 oz
Reason CGMP Deviations
Class II · Moderate risk Terminated
White Liniment packaged in a) 1 oz
Reason CGMP Deviations
Class II · Moderate risk Terminated
Union
Reason CGMP Deviations
Class II · Moderate risk Terminated
Metformin HCL E/R 500 mg
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended Release 750 mg
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk Terminated
N-A-C
Reason Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.
Class II · Moderate risk Terminated
Salicylic Acid Shampoo 3%
Reason GMP Deviations
Class II · Moderate risk Terminated
DCL Clear Skin Anti-Blemish Hydrator
Reason GMP Deviations
Class II · Moderate risk Terminated
DCL Alpha Beta Gel Toner
Reason GMP Deviations
Class II · Moderate risk Terminated
Willa Pore Perfector
Reason GMP Deviations
Class II · Moderate risk Terminated
Willa Clear Skin
Reason GMP Deviations
Class II · Moderate risk Terminated
MD Complete Breakout Treatment
Reason GMP Deviations
Class II · Moderate risk Terminated
(Malin+Goetz) spf 30 face moisturizer
Reason GMP Deviations