Class II · Moderate risk Terminated
Methocarbamol
Reason CGMP Deviations: Lack of quality assurance at the API manufacturer.
FDA Drug Recalls
14,801 recalls, newest first
Class I · High risk Terminated
CaverFlo Natural Herbal Coffee
Reason Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
Class I · High risk Terminated
Brilinta
Reason Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Class III · Low risk Terminated
Ponstel
Reason Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Class III · Low risk Terminated
Mefenamic Acid
Reason Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Class III · Low risk Terminated
Mefenamic Acid Capsules
Reason Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
Class II · Moderate risk Terminated
Caffeine Powder
Reason Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.
Class II · Moderate risk Terminated
Zenatane
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk Terminated
Zenatane
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk Terminated
Zenatane
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk Terminated
Zenatane
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class I · High risk Terminated
Biotech Underground Tri-Ton Hardcore Formula capsules
Reason Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.
Class III · Low risk Terminated
Fludeoxyglucose F 18 Injection
Reason Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Class II · Moderate risk Terminated
Levophed norepinephrine bitartrate
Reason GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Class II · Moderate risk Terminated
Saphris 10 mg
Reason Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Class II · Moderate risk Terminated
PHENYLephrine HCL in 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
HYDROmorphone HCL in 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
morphine sulfate in 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
morphine sulfate in 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.