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.
FDA Drug Recalls
14,450 recalls · Class II, newest first
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
Class II · Moderate risk Terminated
Q.Care Oral Cleansing & Suctioning System q8. Contains 1 Covered…
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 q4. Contains 1 Covered Yankauer
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.CareOral Cleansing & Suctioning System q2. Contains 1 Covered…
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 Petite Size Oral Cleansing & Suctioning System. Contains 1…
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 Petite Size Oral Cleansing & Suctioning System. Contains 1…
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
Toothette Oral Care Suction Toothbrush with Antiseptic Oral…
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
Toothette Oral Care Suction Toothbrush with Perox-A-Mint…
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
Toothette Oral Care Suction Swabs with Perox-A-Mint solution…
Reason Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products