Class II · Moderate risk Terminated
Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection…
Reason Subpotent Drug
FDA Drug Recalls
11,815 recalls · Class II, newest first
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 II · Moderate risk Terminated
Choice Antibacterial Hand Soap
Reason GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Class II · Moderate risk Terminated
Mild Healthcare Antibacterial Hand Soap
Reason GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Class II · Moderate risk Terminated
Option Systems Antibacterial Foaming Hand Wash
Reason GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
Class II · Moderate risk Terminated
Ketorolac Trom 30 mg/mL Injection
Reason Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
Class II · Moderate risk Terminated
Levophed
Reason Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Class II · Moderate risk Terminated
HYDROmorphone HCl Injection
Reason Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Class II · Moderate risk Terminated
Ninjacof-A
Reason Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class II · Moderate risk Terminated
Ninjacof
Reason Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class II · Moderate risk Terminated
Nose to Toes Skin Antisepsis
Reason Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk Terminated
Skin antisepsis and oral cleansing. Contains Three 2-packs of 2%…
Reason Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk Terminated
Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate
Reason Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk Terminated
Q Care Oral Cleansing & Suctioning System compatible with 0.12%…
Reason Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk Terminated
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12%…
Reason Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk Terminated
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12%…
Reason Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products