Class II · Moderate risk
Nystatin Oral Suspension
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
FDA Drug Recalls
390 recalls · Class II, newest first
Class II · Moderate risk
Clindamycin Phosphate and Benzoyl Peroxide Gel
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Class II · Moderate risk
Lactulose Solution
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Class II · Moderate risk
Ondansetron HCI API
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
Senna Syrup
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Senexon Liquid
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Diocto Syrup
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Aller-Chlor
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Ninjacof-A
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Ninjacof (chlophedianol HCl and pyrilamine maleate)
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Sennazon (sennosides)
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Sulfacetamide Sodium Ophthalmic Solution
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Class II · Moderate risk
Better Braids Un-Braid
Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
Class II · Moderate risk
Medicated Better Braids
Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result.
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
tubby todd Bath Co
Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.
Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class II · Moderate risk
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.