Class III · Low risk Terminated
Metformin Hydrochloride Tablets
Reason Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Norco
Reason Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Class III · Low risk Terminated
Fentanyl Transdermal System
Reason Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk Terminated
Fentanyl Transdermal System. 75 mcg/h
Reason Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk Terminated
Fentanyl Transdermal System
Reason Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk Terminated
Fentanyl Transdermal System. 25 mcg/h
Reason Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk Terminated
Atorvastatin Calcium Tablets 40 mg
Reason Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk Terminated
Atorvastatin Calcium Tablets 20 mg
Reason Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk Terminated
Atorvastatin Calcium Tablets 10 mg
Reason Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk Terminated
Megestrol Acetate Oral Suspension
Reason Subpotent Drug: Out of specification for assay (stability testing)
Class III · Low risk Terminated
Life Brand Clear Action Acne Treatment Concealer Stick
Reason Superpotent drug: failed assay throughout the stick after 6 months stability.
Class III · Low risk Terminated
Cefuroxime
Reason Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Class III · Low risk Terminated
Ultane
Reason Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Class III · Low risk Terminated
Oxycodone Hydrochloride Tablets
Reason Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Class III · Low risk Terminated
Ciclopirox Olamine Cream USP
Reason Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Class III · Low risk Terminated
Vecuronium bromide for Injection
Reason Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Class III · Low risk Terminated
Simvastatin Tablets
Reason Presence of foreign substance: metallic razor blade was found in one bottle.
Class III · Low risk Terminated
Clobetasol Propionate Cream USP
Reason Failed Content Uniformity Specifications
Class III · Low risk Terminated
Methylphenidate Hydrochloride Extended-release Tablets
Reason Subpotent Drug
Class III · Low risk Terminated
Methylphenidate Hydrochloride Extended-release Tablets
Reason Subpotent Drug
Class III · Low risk Terminated
Gabapentin Oral Solution
Reason CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Class III · Low risk Terminated
Auryxia
Reason Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
Class III · Low risk Terminated
Enoxaparin Sodium
Reason Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
Class III · Low risk Terminated
Bull Capsules
Reason Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
Class III · Low risk Terminated
Penicillin V Potassium for Oral Solution
Reason Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.