Class II · Moderate risk Terminated
MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%
Reason CGMP Deviations
FDA Drug Recalls
11,815 recalls · Class II, newest first
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.
Class II · Moderate risk Terminated
Nystatin Oral Suspension
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Phenytoin Oral Suspension
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Metoclopramide 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
Hydrocodone Bitartrate and Acetaminophen 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
Nystatin Oral Suspension
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Duopa
Reason Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
Class II · Moderate risk Terminated
Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Docetaxel Injection USP
Reason Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.
Class II · Moderate risk Terminated
Fluconazole Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Fluconazole Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Alfuzosin Hydrochloride Extended-release Tablets
Reason Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
Class II · Moderate risk Terminated
Flucanozole Tablets
Reason Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk Terminated
Flucanozole Tablets
Reason Failed Dissolution Specifications; 18 month stability time point