Class III · Low risk Terminated
ENALAPRIL MALEATE Tablets
Reason Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Sterile Water for Injection
Reason Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class II · Moderate risk Terminated
Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL bag
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Fosphenytoin Sodium Injection
Reason Presence of Particulate Matter
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk Terminated
Doctor Manzanilla Cough & Cold
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
Doctor Manzanilla Allergy & Decongestant Relief
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class I · High risk Terminated
Vancomycin Hydrochloride for Injection
Reason Presence of Particulate Matter: glass particulate found in vial