Class II · Moderate risk
Silicea 6X Tablets
CGMP Deviations: products were not manufactured under 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
Natrum Sulphuricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Natrum Phosphoricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Natrum Muriaticum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Magnesia Phosphorica 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Kali Sulphuricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Kali Phosphoricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Kali Muriaticum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Ferrum Phosphoricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Cell Salts Combination 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Calcarea Sulphurica 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Calcarea Phosphorica 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Calcarea Fluorica 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9%…
GMP Deviations: potential glass contamination
Class II · Moderate risk
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9%…
GMP Deviations: potential glass contamination
Class II · Moderate risk
PF-Fentanyl Citrate
GMP Deviations: potential glass contamination
Class III · Low risk
Ranitidine Tablets USP
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Class II · Moderate risk
Fentanyl Citrate USP
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
Class III · Low risk
Matzim LA (Diltiazem Hydrochloride)
GMP Deviation: lot not intended for commercial distribution.
Class II · Moderate risk
5% Acetyl-L-Cysteine Ophthalmic Solutions
Lack of Processing Controls:
Class II · Moderate risk
10% Acetyl-L-Cysteine Ophthalmic Solutions
Lack of Processing Controls:
Class II · Moderate risk
20% Acetyl-L-Cysteine Ophthalmic Solutions
Lack of Processing Controls:
Class II · Moderate risk
Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine…
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
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