Class II · Moderate risk Terminated
(Malin + Goetz) Salicylic Gel
Reason GMP Deviations
FDA Drug Recalls
14,450 recalls · Class II, newest first
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 II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets USP 750 mg
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk Terminated
Bupivacaine Hydrochloride in 8.25% Dextrose Injection
Reason Presence of particulate matter in solution - black and transparent particles
Class II · Moderate risk Terminated
metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals…
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk Terminated
metformin HCL ER 500 mg
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk Terminated
Catapres
Reason An extraneous peak was observed for dissolution testing.
Class II · Moderate risk Terminated
Catapres
Reason An extraneous peak was observed for dissolution testing.
Class II · Moderate risk Terminated
Catapres
Reason An extraneous peak was observed for dissolution testing.
Class II · Moderate risk Terminated
Time-Cap Labs
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Time-Cap Labs
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Chlorhexidine Gluconate 20% 0012 Medichem
Reason Discoloration.
Class II · Moderate risk Completed
SYP Health Hand Sanitizer Alcohol Gel
Reason CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk Terminated
Riomet ER
Reason CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Class II · Moderate risk Terminated
Nature-Throid 1 GR
Reason CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
Class II · Moderate risk Terminated
Albuterol Sulfate Inhalation Aerosol
Reason Defective Delivery System: Sustained trend of failure to dispense complaints.
Class II · Moderate risk Terminated
Phentermine
Reason cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk Terminated
Diethylpropion
Reason cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk Terminated
Diethylpropion
Reason cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.