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 drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
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.
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Clindamycin Phosphate and Benzoyl Peroxide Gel
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Class II · Moderate risk
Venlafaxine Hydrochloride extended release capsules
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Class II · Moderate risk
Furosemide Tablets USP
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Class II · Moderate risk
Nadolol Tablets
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Subpotency: due to a low, out of specification test result for assay during stability testing.
Class II · Moderate risk
Lisinopril tablets
Failed tablet/capsule specification: missing break line on the 5mg tablet.
Class II · Moderate risk
Temozolomide Capsules
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class II · Moderate risk
Temozolomide Capsules
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class II · Moderate risk
Temozolomide Capsules
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class II · Moderate risk
Temozolomide Capsules
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class II · Moderate risk
Midazolam Injection
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Gentell Hydrogel Wound Dressing REGULAR
CGMP Deviations
Class II · Moderate risk
Gentell Hydrogel Ag Saturated Gauze
CGMP Deviations
Class II · Moderate risk
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution
Lack of Sterility Assurance
Class II · Moderate risk
AMGEN Kyprolis
Lack of Assurance of Sterility: Potential cracks in glass vials
Class II · Moderate risk
Torsemide Tablets
CGMP Deviations
Class II · Moderate risk
Torsemide Tablets
CGMP Deviations