Class II · Moderate risk Terminated
Benzoyl Peroxide 5% Clindamycin 1.2%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Adapalene 0.1%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Bicarbonate 10%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
MINOXADIL all strength including 2%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
5-Fluorouracil in Vanicream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Ketoconazole 2%/Hydrocortisone 1.5% Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
HCG and HCG with resveratrol Human Chorionic Gonadotropin in…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
CANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Pioglitazone and Glimepiride Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
METRONIDazole Injection
Reason Lack of Sterility Assurance: customer report of leaking bag
Class II · Moderate risk Terminated
CycloSPORINE Capsules
Reason Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
Class II · Moderate risk Terminated
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Indocin
Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Class II · Moderate risk Terminated
Glipizide 2.5 mg ER Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
GlipiZIDE Extended-release tablets
Reason Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Class II · Moderate risk Terminated
CycloSPORINE Capsules
Reason Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Class II · Moderate risk Terminated
Transderm Scop
Reason Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.
Class II · Moderate risk Terminated
Mimvey Lo
Reason Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Class II · Moderate risk Terminated
Glipizide extended-release tablets
Reason Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Class II · Moderate risk Terminated
Mirtazapine Tablets
Reason Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Class II · Moderate risk Terminated
MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%
Reason CGMP Deviations
Class II · Moderate risk Terminated
MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%
Reason CGMP Deviations
Class II · Moderate risk Terminated
MakeSense PHARMA Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMIN E
Reason CGMP Deviations