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Showing 5901–5920 of 15081 results

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Sodium Bicarbonate Bag (CMC Enterprise) – Sterility Risk (2019)

Lack of sterility assurance.

Class IIModerate

FDAApr 12, 2019NC• CMC Enterprise Pharmacy

Vancomycin Sodium Chloride Bag (CMC Enterprise) – Sterility Issue (2019)

Lack of sterility assurance.

Class IIModerate

FDAApr 12, 2019NC• CMC Enterprise Pharmacy

Norepinephrine NS Bag (CMC Enterprise) – Sterility Issue (2019)

Lack of sterility assurance.

Class IIModerate

FDAApr 12, 2019NC• CMC Enterprise Pharmacy

Lidocaine Buffered J-Tip Syringe (CMC Enterprise) – Sterility Concern (2019)

Lack of sterility assurance.

Class IIModerate

FDAApr 12, 2019NC• CMC Enterprise Pharmacy

Divalproex Sodium Tablets (Dr. Reddy's) – Humidity Exposure (2019)

cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

Class IIModerate

FDAApr 11, 2019Nationwide• Dr. Reddy's Laboratories, Inc.

Morphine Sulfate 60mg Tablets (Lupin) – Impurity Specifications (2019)

Failed Impurities/Degradation Specifications

FDAApr 10, 2019Nationwide• LUPIN SOMERSET

Morphine Sulfate 100mg Tablets (Lupin) – Impurity Specifications (2019)

Failed Impurities/Degradation Specifications

FDAApr 10, 2019Nationwide• LUPIN SOMERSET

Morphine Sulfate Tablets 30mg (Lupin Somerset) – Impurity Concern (2019)

Failed Impurities/Degradation Specifications

FDAApr 10, 2019Nationwide• LUPIN SOMERSET

Morphine Sulfate 200mg Tablets (Lupin) – Impurity Specifications (2019)

Failed Impurities/Degradation Specifications

FDAApr 10, 2019Nationwide• LUPIN SOMERSET

Morphine Sulfate Tablets 15mg (Lupin Somerset) – Impurity Concern (2019)

Failed Impurities/Degradation Specifications

FDAApr 10, 2019Nationwide• LUPIN SOMERSET

Aphrodisiac Platinum 40000 (Select Distributions) – Sildenafil Contamination (2019)

Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil

FDAApr 9, 2019MI, OH• SELECT DISTRIBUTIONS LLC

Test PROCYP Injectable (Customceutical) – Sterility Risk (2019)

Lack of assurance of sterility for injectables and solutions intended to be sterile.

Class IIModerate

FDAApr 8, 2019Nationwide• Customceutical Compounding

Lipoplex Injectable (Customceutical) – Sterility Risk (2019)

Lack of assurance of sterility for injectables and solutions intended to be sterile.

Class IIModerate

FDAApr 8, 2019Nationwide• Customceutical Compounding

GlipiZIDE Extended-release Tablets (American Health) – Dissolution Failure (2019)

Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.

Class IIModerate

FDAApr 8, 2019Nationwide• American Health Packaging

TriMix MEDIUM Injectable (Customceutical) – Sterility Risk (2019)

Lack of assurance of sterility for injectables and solutions intended to be sterile.

Class IIModerate

FDAApr 8, 2019Nationwide• Customceutical Compounding

Test D Injectable (Customceutical) – Sterility Risk (2019)

Lack of assurance of sterility for injectables and solutions intended to be sterile.

Class IIModerate

FDAApr 8, 2019Nationwide• Customceutical Compounding

Test D Injectable (Customceutical) – Sterility Risk (2019)

Lack of assurance of sterility for injectables and solutions intended to be sterile.

Class IIModerate

FDAApr 8, 2019Nationwide• Customceutical Compounding

HCG Injectable (Customceutical) – Sterility Risk (2019)

Lack of assurance of sterility for injectables and solutions intended to be sterile.

Class IIModerate

FDAApr 8, 2019Nationwide• Customceutical Compounding

Trimix HIGH Injectable (Customceutical) – Sterility Risk (2019)

Lack of assurance of sterility for injectables and solutions intended to be sterile.

Class IIModerate

FDAApr 8, 2019Nationwide• Customceutical Compounding

BPlex Injectable (Customceutical) – Sterility Risk (2019)

Lack of assurance of sterility for injectables and solutions intended to be sterile.

Class IIModerate

FDAApr 8, 2019Nationwide• Customceutical Compounding

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