Class III · Low risk Terminated
Enalapril Maleate Tablets
Reason Failed Stability Specifications
FDA Drug Recalls
14,801 recalls, newest first
Class I · High risk Terminated
PIYANPING Anti-Itch
Reason Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Class III · Low risk Terminated
Propafenone Hydrochloride tablets
Reason Failed moisture limits: Out of specification for moisture content.
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
Class II · Moderate risk Terminated
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush…
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 Suction Toothbrush…
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 Suction Toothbrush…
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 Suction Toothbrush…
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 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 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 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 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