Class II · Moderate risk Ongoing
BD ChloraPrep" Triple Swabsticks
Reason Lack of Assurance of Sterlity
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Oxycodone and Acetaminophen CII Tablets USP
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk Ongoing
Oxycodone and Acetaminophen CII Tablets USP
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk Ongoing
Noxafil Powdermix
Reason Presence of particulate matter: potential presence of metal particulates in the product.
Class II · Moderate risk Ongoing
Merck Emend
Reason Presence of particulate matter: potential presence of metal particulates in the product.
Class II · Moderate risk Ongoing
Ciclopirox Shampoo
Reason Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Class II · Moderate risk Ongoing
ORL Kids Natural Toothpaste
Reason cGMP Deviations
Class II · Moderate risk Ongoing
ORL Kids Mouthwash
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Baclofen Tablets USP
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · Moderate risk Ongoing
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Reason Incorrect Product Formulation
Class II · Moderate risk Ongoing
Ondansetron ODT Tablets
Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Ongoing
Ganirelix Acetate Injection
Reason Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Class II · Moderate risk Ongoing
Walgreens Saline Nasal Spray WITH XYLITOL
Reason Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Class II · Moderate risk Ongoing
Sertraline Hydrochloride Tablets USP
Reason Defective container - seal not adhering to bottles
Class II · Moderate risk Ongoing
OraVerse
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
Cook-Walte
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
Benco dental Graham CHEMICAL CO.
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
darby dental supply
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
3% Polocaine DENTAL
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
Lidocaine HCI 2% and Epinephrine 1:100
Reason Defective container: cracked/broken cartridges