Class II · Moderate risk Terminated
Restore Sinus Spray
Reason Microbial contamination of Non-Sterile Products
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
ION* Sinus Support Nasal Spray
Reason Microbial contamination of Non-Sterile Products
Class II · Moderate risk Ongoing
Gynazole-1
Reason Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Class II · Moderate risk Ongoing
Triamcinolone Acetonide Injectable Suspension
Reason Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
Class II · Moderate risk Terminated
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
HYDROmorphone in dextrose 5%
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
HYDROmorphone in 0.9% Sodium Chloride
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
HYDROmorphone in dextrose 5%
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
HYDROmorphone in 0.9% sodium chloride
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
HYDROmorphone in 0.9% sodium chloride
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
HYDROmorphone in 0.9% sodium chloride
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
succinylcholine
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL in dextrose 5%
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
midazolam in dextrose 5%
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride
Reason Lack of assurance of sterility: