Class II · Moderate risk
Sodium Chloride Injection
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Metformin HCl Extended Release Tablets USP 500 mg
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg
Failed Dissolution Specification
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg
Failed Dissolution Specification
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets
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
Vapor Ointment packaged in a) 1/8 oz
CGMP Deviations
Class II · Moderate risk
White Liniment packaged in a) 1 oz
CGMP Deviations
Class II · Moderate risk
Union (black)
CGMP Deviations
Class II · Moderate risk
Metformin HCL E/R 500 mg
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk
Metformin Hydrochloride Extended Release 750 mg
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk
N-A-C
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
Salicylic Acid Shampoo 3%
GMP Deviations
Class II · Moderate risk
DCL Clear Skin Anti-Blemish Hydrator
GMP Deviations
Class II · Moderate risk
DCL Alpha Beta Gel Toner
GMP Deviations
Class II · Moderate risk
Willa Pore Perfector
GMP Deviations
Class II · Moderate risk
Willa Clear Skin
GMP Deviations
Class II · Moderate risk
MD Complete Breakout Treatment
GMP Deviations
Class II · Moderate risk
(Malin+Goetz) spf 30 face moisturizer
GMP Deviations
Class II · Moderate risk
(Malin + Goetz) Salicylic Gel
GMP Deviations
Class II · Moderate risk
Class II · Moderate risk
DCL T Shampoo for Hair and Body
GMP Deviations
Class II · Moderate risk
DCL SA Scalp Therapy Shampoo
GMP Deviations
Class II · Moderate risk
DCL AHA Lightening Gel
GMP Deviations