Class II · Moderate risk
STELLALIFE ADVANCED FORMULA Peppermint
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
FDA Drug Recalls
337 recalls · Class II, newest first
Class II · Moderate risk
Little Remedies Gas Relief Drops
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Class II · Moderate risk
Restore Sinus Spray
Microbial contamination of Non-Sterile Products
Class II · Moderate risk
ION* Sinus Support Nasal Spray
Microbial contamination of Non-Sterile Products
Class II · Moderate risk
Endometrin
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Common Sense Fragrance Free Hand Sanitizer
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Protect U Guard Foaming Hand Sanitizer
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Protect U Guard Foaming Hand Sanitizer Ophardt
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Stage 2-Ophardt Foaming Hand Sanitizer
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Avant Foaming Hand Sanitizer Ophardt
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Avant Foaming Hand Sanitizer
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Earache Drops
Microbial contamination of non-sterile product.
Class II · Moderate risk
Homeopathic EarAche Ear Drops
Microbial contamination of non-sterile product.
Class II · Moderate risk
Homeopathic EarAche Drops
Microbial contamination of non-sterile product.
Class II · Moderate risk
Zonisamide Capsules USP
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
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 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.