Class II · Moderate risk
Nasal Decongestant Spray Regular
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
FDA Drug Recalls
1,586 recalls · Class II, newest first
Class II · Moderate risk
Pseudoephedrine Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Banophen Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Robafen DM Syrup
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Robafen AC Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Robafen Cough Formula Expectorant
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Children's Mapap Acetaminophen Liquid
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Allergy Liquid Antihistamine
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Children's Acetaminophen Liquid
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
RisperiDONE Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Amitiza (lubiprostone)
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
Amitiza (lubiprostone)
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
Anastrozole Tablets
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Class II · Moderate risk
Anastrozole Tablets
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 1 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.