Class I · High risk
SENNA Syrup
Microbial Contamination of Non-Sterile Product
FDA Drug Recalls
9 recalls · Class I, newest first
Class I · High risk
Clobetasol Propionate Ointment USP
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class I · High risk
Ruzurgi (amifampridine)
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Class I · High risk
Avicel RC-591 NF
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Class I · High risk
Lite'n Foamy Lemon Blossom Hand Sanitizer
Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
Class I · High risk
ChloraPrep With Tint 2% w/v chlorhexidine gluconate
Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Class I · High risk
ChloraPrep One-Step 2% w/v chlorhexidine gluconate
Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Class I · High risk
Durisan Antimicrobial Solutions
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
Durisan Antimicrobial Solutions
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.