Class II · Moderate risk
Manufacturing (cGMP) deviations
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards.
1,754 FDA drug recalls with this cause, newest first.
This category covers departures from current Good Manufacturing Practice during production. It is FDA's broadest label, used when a facility's own process control failed somewhere along the line even if no single ingredient was proven unsafe on its own. Where the report names a specific consequence - a temperature excursion, a contaminant, a potency problem - we file the recall under that more specific cause instead; what remains here is the genuinely general case.
Class II · Moderate risk
Class II · Moderate risk
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70
cGMP Deviations
Class II · Moderate risk
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45
cGMP Deviations
Class II · Moderate risk
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30
cGMP Deviations
Class II · Moderate risk
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70
cGMP Deviations
Class II · Moderate risk
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Neutrogena COOLDRY SPORT sunscreen spray SPF 30
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
MIC+Methyl B12 injection Methionine Inositol…
Lack of processing controls
Class II · Moderate risk
Zyprexa Intramuscular
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Class II · Moderate risk
Solifenacin Succinate Tablets
CGMP Deviations
Class II · Moderate risk
Oxygen
cGMP deviations
Class II · Moderate risk
Lite'n Foamy Healthcare Personnel Handwash
CGMP Deviations
Class II · Moderate risk
Lite'n Foamy Eucalyptus Mint Sanitizing Handwash
CGMP Deviations
Class II · Moderate risk
Lite'n Foamy E2 Sanitizing Handwash
CGMP Deviations
Class II · Moderate risk
Antiseptic Hand Cleaner
CGMP Deviations
Class II · Moderate risk
foamyiQ Lemon Blossom Hand Sanitizer
CGMP Deviations
Class II · Moderate risk
Mometasone Furoate Topical Solution
CGMP Deviaitons
Class II · Moderate risk
aulief (Organic Camphor 3.00% Organic Menthol 5.00%)
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class II · Moderate risk
China-Gel White
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class II · Moderate risk
CHINA_GEL (Camphor 3.00%, Menthol 5.00%)
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
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