Class II · Moderate risk
aulief (Organic Camphor 3.00% Organic Menthol 5.00%)
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
FDA Drug Recalls
921 recalls · Class II, newest first
Class II · Moderate risk
China-Gel White
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class II · Moderate risk
CHINA_GEL (Camphor 3.00%, Menthol 5.00%)
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class II · Moderate risk
Durisan Antimicrobial Solutions
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Class II · Moderate risk
Durisan Antimicrobial Solutions
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Class II · Moderate risk
0.9% SODIUM CHLORIDE Irrigation
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Class II · Moderate risk
Gabapentin Oral Solution
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Class II · Moderate risk
Nortriptyline HCL capsules
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Class II · Moderate risk
Progesterone Capsules
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel.
Class II · Moderate risk
Fludeoxyglucose F 18 Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Imatinib Mesylate Tablets 100mg
Failed Dissolution Specifications
Class II · Moderate risk
Metoclopramide Injection USP
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
MethyIPREDNISolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
MethyIPREDNISolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
MethyIPREDNISolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
MethyIPREDNISolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Epoprostenol Sodium for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Vecuronium Bromide for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Toposar (etoposide injection USP)
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.