Class II · Moderate risk Terminated
Flucanozole Tablets
Reason Failed Dissolution Specifications; 18 month stability time point
FDA Drug Recalls
14,801 recalls, newest first
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 III · Low risk Terminated
Aripiprazole Tablets
Reason Superpotent Drug; out of specification results for assay (manufacturer)
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 III · Low risk Terminated
Temazepam Capsules USP
Reason Failed Stability Specifications
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 III · Low risk Terminated
buPROPion Hydrochloride Extended-release Tablets
Reason Failed Dissolution Specifications; 18 month stability time point
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-release Tablets
Reason Failed Dissolution Specifications; 18 month stability time point
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.
Class III · Low risk Terminated
Aripiprazole Tablets
Reason Superpotent Drug: Product may not meet specifications throughout shelf life.
Class III · Low risk Terminated
Pantoprazole Sodium for Injection
Reason Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Class II · Moderate risk Terminated
Midazolam Injection
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Gentell Hydrogel Wound Dressing REGULAR
Reason CGMP Deviations
Class II · Moderate risk Terminated
Gentell Hydrogel Ag Saturated Gauze
Reason CGMP Deviations
Class II · Moderate risk Terminated
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
AMGEN Kyprolis
Reason Lack of Assurance of Sterility: Potential cracks in glass vials