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Showing 5421–5440 of 14370 results

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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

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

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

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

Glutathione 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 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

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 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

Telmisartan Amlodipine Tablets (AVKARE) – Impurity Concern (2019)

Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)

FDAApr 3, 2019AZ, CO• AVKARE Inc.

Vitamin D3 200,000 IU/mL Injection (Anderson) – sterility issue (2019)

Lack of sterility assurance.

Class IIModerate

FDAApr 2, 2019Nationwide• Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Heparin Lidocaine Injection (Anderson Compounding) – Sterility Risk (2019)

Lack of sterility assurance.

Class IIModerate

FDAApr 2, 2019Nationwide• Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Remifentanil HCl API (Johnson Matthey) – impurity specification issue (2019)

Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.

FDAApr 2, 2019Nationwide• Johnson Matthey Inc.

Heparin/Lidocaine Mixture (Anderson Compounding) – sterility concern (2019)

Lack of sterility assurance.

Class IIModerate

FDAApr 2, 2019Nationwide• Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Lidocaine/Dextrose Injection (Anderson Compounding) – sterility concern (2019)

Lack of sterility assurance.

Class IIModerate

FDAApr 2, 2019Nationwide• Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Telmisartan Amlodipine Tablets (Lupin) – impurity specification (2019)

Failed Impurities/Degradation Specifications; 18 month long term stability study.

FDAApr 1, 2019Nationwide• Lupin Pharmaceuticals Inc.

Clonidine HCL Injection (X-Gen) – Labeling Error (2019)

Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.

FDAMar 29, 2019Nationwide• X-Gen Pharmaceuticals Inc.

Pantoprazole Sodium Tablets (Jubilant Cadista) – Tablet Discoloration (2019)

Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.

Class IIModerate

FDAMar 29, 2019Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Addback Tablet (Cays) – undeclared coating ingredients (2019)

Undeclared Allergen

Undeclared coating ingredients: HPMC, Triacetin, Titanium Dioxide, FD & C Yellow # 5, FD & C Yellow # 6, FD & C Blue # 1. In addition, the label states Silicon Dioxide, which is not part of the formulation

Class IIModerate

FDAMar 29, 2019IN• Cays LLC

Nystatin Oral Suspension (Akorn) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.

FDAMar 28, 2019AR, MS• Akorn, Inc.

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