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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

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

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

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

Kopi Jantan Coffee (Brian P. Richardson) – Undeclared Drug Risk (2019)

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

Methionine/Choline Injection (Anderson Compounding) – sterility concern (2019)

HCG 23 Day Injection (Anderson Compounding) – sterility concern (2019)

Heparin 20,000U/Marcaine Mixture (Anderson) – sterility issue (2019)

Prostaglandin 60 mcg/mL (Anderson) – sterility issue (2019)

Prostaglandin Tri-Mix 8.33:22.5 Injection (Anderson) – sterility issue (2019)

Bacitracin Irrigation (Anderson Compounding) – Sterility Issue (2019)

HCG 1,000 U/mL (Anderson Compounding) – sterility concern (2019)

HCG Injection (Anderson Compounding) – sterility concern (2019)

Prostaglandin Tri-Mix 60:30:1 (Anderson Compounding) – sterility concern (2019)

Serum Tears 50% (Anderson Compounding) – sterility concern (2019)

Papaverine Injection (Anderson Compounding) – sterility concern (2019)

Methylcobalamin Injection (Anderson Compounding) – Sterility Issue (2019)

Prostaglandin Tri-Mix 5:15:0.5 Injection (Anderson) – sterility issue (2019)

Acetylcysteine 10% Eye Drops (Anderson Compounding) – sterility concern (2019)

Estradiol Cypionate 10 mg/mL (Anderson) – sterility issue (2019)

Morphine Sulfate Inhalation (Anderson Compounding) – Sterility Issue (2019)