Class II · Moderate risk
TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%
Lack of Assurance of Sterility: There are also CGMP Deviations.
FDA Drug Recalls
893 recalls · Class II, newest first
Class II · Moderate risk
Ketoconazole 2%/Hydrocortisone 1.5% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
HCG and HCG with resveratrol Human Chorionic Gonadotropin in…
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
CANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Human Chorionic Gonadotropin
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Pioglitazone and Glimepiride Tablets
Failed Dissolution Specifications
Class II · Moderate risk
METRONIDazole Injection
Lack of Sterility Assurance: customer report of leaking bag
Class II · Moderate risk
CycloSPORINE Capsules
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Indocin (Indomethacin)
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
Glipizide 2.5 mg ER Tablets
Failed Dissolution Specifications
Class II · Moderate risk
GlipiZIDE Extended-release tablets
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Class II · Moderate risk
CycloSPORINE Capsules
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Class II · Moderate risk
Transderm Scop
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
Mimvey Lo (estradiol and norethindrone acetate tablets USP)
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Class II · Moderate risk
Glipizide extended-release tablets
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Class II · Moderate risk
Mirtazapine Tablets
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Class II · Moderate risk
MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%
CGMP Deviations
Class II · Moderate risk
MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%
CGMP Deviations
Class II · Moderate risk
MakeSense PHARMA
CGMP Deviations
Class II · Moderate risk
Calcipotriene Cream 0.0005%
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Class II · Moderate risk
Mirtazapine Tablets
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Class II · Moderate risk
glipiZIDE Extended-Release Tablets
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets