Class II · Moderate risk Terminated
Biscolax Laxative
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Pedia Relief Cough-Cold 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 Cough Sugar-Free Clear Cough Expectorant
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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).
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 III · Low risk Terminated
Betamethasone Dipropionate Ointment USP
Reason Failed Impurities/Degradation Specifications
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 I · High risk Terminated
Promacta
Reason Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Class III · Low risk Terminated
QUIK-CARE Aerosol Foam Hand Sanitizer
Reason Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.
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.