Class II · Moderate risk Terminated
Ganirelix Acetate Injection
Reason Failed Impurities/Degradation Specifications
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
ZOMA-Jet 10 Demonstration Kit
Reason Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II · Moderate risk Terminated
ZOMA-Jet 5 Demonstration Kit
Reason Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II · Moderate risk Terminated
Omeprazole Delayed-Release Capsules
Reason Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Class II · Moderate risk Terminated
Phenylephrine HCl Injection
Reason Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Class II · Moderate risk Ongoing
aulief
Reason 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 Ongoing
China-Gel White
Reason 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 Ongoing
China_gel
Reason 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 Terminated
Durisan Antimicrobial Solutions
Reason 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 Terminated
Durisan Antimicrobial Solutions
Reason CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Class I · High risk Terminated
Durisan Antimicrobial Solutions
Reason Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
Class I · High risk Terminated
Durisan Antimicrobial Solutions
Reason Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
Class I · High risk Terminated
heal the world
Reason Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class III · Low risk Terminated
Tremfya
Reason Temperature Abuse
Class II · Moderate risk Terminated
0.9% SODIUM CHLORIDE Irrigation
Reason Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Class II · Moderate risk Terminated
Gabapentin Oral Solution
Reason Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Class III · Low risk Terminated
Romidepsin Injecton
Reason Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Class I · High risk Terminated
Acetaminophen
Reason Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
Class II · Moderate risk Terminated
Nortriptyline HCL capsules
Reason 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 III · Low risk Terminated
Menopur 75 IU
Reason Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Class II · Moderate risk Terminated
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg
Reason Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Class II · Moderate risk Terminated
Progesterone Capsules
Reason Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Class III · Low risk Terminated
Cequa
Reason Subpotent
Class III · Low risk Terminated
Methylprednisolone Tablets USP
Reason Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel.