Class II · Moderate risk Terminated
Nasal Decongestant Spray Regular
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Pseudoephedrine Oral Solution
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Banophen Oral Solution
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Robafen DM Syrup
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Robafen AC Oral Solution
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Robafen Cough Formula Expectorant
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Children's Mapap Acetaminophen Liquid
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Allergy Liquid Antihistamine
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Children's Acetaminophen Liquid
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
RisperiDONE Oral Solution
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk Terminated
Amitiza
Reason Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Class II · Moderate risk Terminated
Amitiza
Reason Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Class II · Moderate risk Terminated
Anastrozole Tablets
Reason GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Class II · Moderate risk Terminated
Anastrozole Tablets
Reason GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Class II · Moderate risk Terminated
MethylPREDNISolone Tablets
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
MethylPREDNISolone Tablets
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
MethylPREDNISolone Tablets
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
MethylPREDNISolone Tablets
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
MethylPREDNISolone Tablets
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets 1 mg
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.