Class II · Moderate risk
Asma Aid Distributed by Herbal Doctor Remedies Alhambra
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
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
Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone…
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Class II · Moderate risk
Sn-Pyrophosphate Kit
Lack of Processing Controls.
Class II · Moderate risk
Sn-Tetrofosmin Kit 5.0 mL
Lack of Processing Controls.
Class II · Moderate risk
Sn-DTPA Kit 10 mg
Lack of Processing Controls.
Class II · Moderate risk
Sn-d
Lack of Processing Controls.
Class II · Moderate risk
Sulfur Colloid Reaction Vial 1.0 mL
Lack of Processing Controls.
Class II · Moderate risk
Sn-Mertiatide Kit
Lack of Processing Controls.
Class II · Moderate risk
Sn-DMSA solution
Lack of Processing Controls.
Class II · Moderate risk
Pentreotide
Lack of Processing Controls.
Class II · Moderate risk
Unison Hand Care Products
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Antibacterial Hand Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Sani-Guard-SF Waterless Foam Hand Sanitizer
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Mild Health Care Antibacterial Hand Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Antibacterial Hand Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
INODERM Antiseptic Hand Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Instant Waterless Hand Sanitizer
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
AQUACIL instant foaming hand sanitizer
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Class II · Moderate risk
0.9% Sodium Chloride Injection
CGMP Deviations
Class II · Moderate risk
Cephalexin for Oral Suspension USP
CGMP Deviation; manufacturing batch record could not be located
Class II · Moderate risk
Cefdinir for Oral Suspension USP
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Class II · Moderate risk
Cefdinir for Oral Suspension USP
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
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