Class II · Moderate risk Terminated
VERMOX Tablets 100 mg
Reason CGMP Deviations
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
tabcin NOCHE
Reason CGMP Deviations
Class II · Moderate risk Terminated
tabcin ACTIVE M.R. Capsules
Reason CGMP Deviations
Class II · Moderate risk Terminated
Tazorac
Reason Failed Content Uniformity Specifications.
Class II · Moderate risk Terminated
Tazorac
Reason Failed Content Uniformity Specifications.
Class II · Moderate risk Terminated
Coppertone SUNSCREEN LOTION
Reason Labeling; Product Contains Undeclared API (Oxybenzone)
Class II · Moderate risk Terminated
Bromocriptine Mesylate Capsules USP
Reason Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
Class II · Moderate risk Terminated
Vancomycin Hydrochloride for Injection
Reason Presence of Particulate Matter: Cardboard
Class II · Moderate risk Terminated
8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.