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.
Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection.
1,002 FDA drug recalls with this cause, newest first.
These recalls involve bacteria, mold, yeast or other microorganisms actually found in the finished product. This overlaps with sterility issues but is tracked separately because it usually points to a specific breakdown - a water system, an unsealed container, a contaminated raw material - rather than a general process failure. It carries a large share of Class I recalls: an organism such as Burkholderia cepacia or Pseudomonas in an eye drop, nasal spray or oral liquid can cause serious infection.
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 II · Moderate risk
Valproic Acid Oral Solution USP
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine With Codeine Oral Solution
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine Syrup Plain
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
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.
Class II · Moderate risk
Paroex (Chlorhexidine Gluconate)
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Class I · High risk
ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray
Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
Class I · High risk
Regenecare Ha
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
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