Class II · Moderate risk
Calcarea Phosphorica 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
FDA Drug Recalls
164 recalls, newest first
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.
Class II · Moderate risk
Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen 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
Fentanyl Citrate and Bupivacaine HCL 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
Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen 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
Baclofen and Clonidine HCL and Morphine Sulfate 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
Morphine Sulfate 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
Morphine Sulfate and Bupivacaine HCL 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
Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Clonidine HCL PF 750 mcg/mL/Prialt PF
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Clonidine HCL and Baclofen 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
Clonidine HCL and Baclofen 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
Clonidine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.