Class II · Moderate risk Terminated
Flucanozole Tablets
Reason Failed Dissolution Specifications; 18 month stability time point
FDA Drug Recalls
11,815 recalls · Class II, newest first
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.
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
Class II · Moderate risk Terminated
Torsemide Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Torsemide Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Rabeprazole Sodium Delayed Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
10% Premasol sulfite-free
Reason Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
Class II · Moderate risk Terminated
Fluconazole Injection
Reason Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Class II · Moderate risk Terminated
CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz
Reason CGMP Deviations
Class II · Moderate risk Terminated
Kids' Relief Ear Relief Oral Liquid 0.85 fl oz.
Reason CGMP Deviations
Class II · Moderate risk Terminated
CVS Health Homeopathic Infants Teething Tablets 135 count bottle…
Reason CGMP Deviations