Class II · Moderate risk Terminated
CycloSPORINE Capsules
Reason Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
FDA Drug Recalls
14,450 recalls · Class II, newest first
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
Class II · Moderate risk Terminated
MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%
Reason CGMP Deviations
Class II · Moderate risk Terminated
MakeSense PHARMA
Reason CGMP Deviations
Class II · Moderate risk Terminated
Calcipotriene Cream 0.0005%
Reason 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 Terminated
Mirtazapine Tablets
Reason Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Class II · Moderate risk Terminated
glipiZIDE Extended-Release Tablets
Reason Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Class II · Moderate risk Terminated
Potassium Chloride Oral Solution
Reason Defective Container: Leakage of unit dose cups that may occur at the seal.
Class II · Moderate risk Terminated
Methadone Hydrochloride Oral Concentrate
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Methadone Hydrochloride Oral Concentrate
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Methadone Hydrochloride Oral Concentrate
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Oxycodone Hydrochloride Oral Solution
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Lactulose Solution
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Lactulose Solution
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.