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.
FDA Drug Recalls
14,450 recalls · Class II, newest first
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
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
Class II · Moderate risk Terminated
Clindamycin Phosphate and Benzoyl Peroxide Gel
Reason Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Class II · Moderate risk Terminated
Venlafaxine Hydrochloride extended release capsules
Reason Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Class II · Moderate risk Terminated
Furosemide Tablets USP
Reason Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Class II · Moderate risk Terminated
Nadolol Tablets
Reason Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Class II · Moderate risk Terminated
Amoxicillin for Oral Suspension USP
Reason Subpotency: due to a low, out of specification test result for assay during stability testing.
Class II · Moderate risk Terminated
Lisinopril tablets
Reason Failed tablet/capsule specification: missing break line on the 5mg tablet.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.