Class II · Moderate risk
DERMATONE (titanium oxide 6% and zinc oxide 4.7%)
Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
FDA Drug Recalls
390 recalls · Class II, newest first
Class II · Moderate risk
alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+
Microbial Contamination of a Non-Sterile Product
Class II · Moderate risk
Daptomycin for Injection
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Class II · Moderate risk
Acne Shave 3 Step Shaving System
CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk
Acne Shave
CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk
Acne Shave Post-Shave Moisturizer
CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk
X-Jow (menthol USP)
CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk
READYFLUSH PROTECT with Dimethicone
Microbial Contamination of a Non-Sterile Product.
Class II · Moderate risk
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX
Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
Class II · Moderate risk
Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Gericare Diocto Liquid
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
SDA Senna Syrup
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Geritrex Senna Syrup
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Ritussin DM Dextromethorphan Hydrobormide
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
GeriCare Senna Syrup
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
RPC APAP Elixir
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
RPC Children's Non-Aspirin
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
RPC Senna Syrup
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Preferred Plus Pharmacy Antacid
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Preferred Plus Pharmacy Antacid Extra Strength
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
B Prox 10 Anti-blemish Wash
Microbial Contamination of Non-sterile Product
Class II · Moderate risk
PASTA DE LASSAR ANDROMACO Skin Protection
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Levofloxacin in 5% Dextrose Injection
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Class II · Moderate risk
Levofloxacin in 5% Dextrose Injection
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap