Class I · High risk
SENNA Syrup
Microbial Contamination of Non-Sterile Product
FDA Drug Recalls
21 recalls, newest first
Class I · High risk
Clobetasol Propionate Ointment USP
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class II · Moderate risk
Betaxolol Ophthalmic Solution
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Class II · Moderate risk
Valproic Acid Oral Solution
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Zonisamide 100 mg Capsules
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
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 II · Moderate risk
Rompe Pecho Max Multi-Symptoms Maximum Strength
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho Ex Expectorant
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho DM
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho CF Cold & Flu Advanced Formula
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Artificial Tears Ointment
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
Class II · Moderate risk
Cyclobenzaprine Hydrochloride Tablets
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Class II · Moderate risk
Cyclobenzaprine Hydrochloride Tablets
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Class II · Moderate risk
Cyclobenzaprine Hydrochloride Tablets
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Class II · Moderate risk
Riomet (metformin hydrochloride oral solution)
Microbial Contamination of Non-Sterile Product
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.