Class II · Moderate risk
Potassium Chloride Oral Solution
Defective Container: Leakage of unit dose cups that may occur at the seal.
FDA Drug Recalls
893 recalls · Class II, newest first
Class II · Moderate risk
Methadone Hydrochloride Oral Concentrate
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Methadone Hydrochloride Oral Concentrate
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Methadone Hydrochloride Oral Concentrate
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Lactulose Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Lactulose Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Nystatin Oral Suspension
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Phenytoin Oral Suspension
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Metoclopramide Oral Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Nystatin Oral Suspension
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Duopa (carbidopa and levodopa enteral suspension)
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
Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles
Failed Dissolution Specifications
Class II · Moderate risk
Docetaxel Injection USP
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
Fluconazole Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Fluconazole Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Alfuzosin Hydrochloride Extended-release Tablets
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.