Class II · Moderate risk
Acne Shave 3 Step Shaving System
CGMP Deviations: products may be contaminated with bacteria.
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
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
Class II · Moderate risk
Levetiracetam in 0.54% Sodium Chloride 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
Levetiracetam in 0.75% Sodium Chloride 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
Levetiracetam in 0.82% Sodium Chloride Injection
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
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