Class II · Moderate risk Terminated
Pedi MVI a) 5 mL
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Prednisone 20 mg
Reason Labeling: Not elsewhere classified. NDC number is incorrect on the container.
Class II · Moderate risk Terminated
Baclofen USP powder
Reason Presence of Foreign Substance
Class III · Low risk Terminated
Paricalcitol Capsules
Reason Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk Terminated
Paricalcitol Capsules
Reason Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk Terminated
Paricalcitol Capsules
Reason Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class II · Moderate risk Terminated
Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for…
Reason Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class II · Moderate risk Terminated
Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal
Reason Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class II · Moderate risk Terminated
Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G…
Reason Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class II · Moderate risk Terminated
Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for…
Reason Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Magnesium Sulfate 7-Hydrate
Reason Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Class II · Moderate risk Terminated
Hydrochlorothiazide Capsules
Reason Presence of Particulate Matter
Class III · Low risk Terminated
Epsom Salt
Reason Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).
Class I · High risk Terminated
Auvi-Q
Reason Defective Delivery System; potential to have inaccurate dosage delivery
Class I · High risk Terminated
Auvi-Q
Reason Defective Delivery System; potential to have inaccurate dosage delivery
Class II · Moderate risk Terminated
Kindest Kare Antimicrobial Foaming Handwash
Reason Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient.
Class II · Moderate risk Terminated
Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk Terminated
GRx HiCort 25
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk Terminated
Carbo-O-Philic 40 Gel 40%
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk Terminated
Carbo-O-Philic 40 Cream 40%
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Duloxetine Delayed-release Capsules
Reason Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Class III · Low risk Terminated
Ranitidine Syrup
Reason Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.