Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Terminated
Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100…
Reason Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
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
Class II · Moderate risk Terminated
(Malin + Goetz) Salicylic Gel
Reason GMP Deviations
Class II · Moderate risk Terminated
(Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis
Reason GMP Deviations
Class II · Moderate risk Terminated
DCL T Shampoo for Hair and Body
Reason GMP Deviations
Class II · Moderate risk Terminated
DCL SA Scalp Therapy Shampoo
Reason GMP Deviations
Class II · Moderate risk Terminated
DCL AHA Lightening Gel
Reason GMP Deviations
Class II · Moderate risk Terminated
DCL B Prox10 Anti-Blemish Wash
Reason GMP Deviations
Class II · Moderate risk Terminated
DCL Active Mattifying Cleanser
Reason GMP Deviations
Class III · Low risk Terminated
Dextroamphetamine Saccharate
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk Terminated
Dextroamphetamine Saccharate
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk Terminated
Dextroamphetamine Saccharate
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.