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Showing 5841–5860 of 15081 results

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Revonto Injection (US Worldmeds) – Precipitate Issue (2019)

Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.

Class IIModerate

FDAApr 25, 2019Nationwide• US Worldmeds LLC

Carvedilol Tablets (Zydus) – Label Mix-up (2019)

Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg

Class IIModerate

FDAApr 25, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Dermoplast Spray (Advantice Health) – Incorrect Weight Label (2019)

Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.

FDAApr 25, 2019Nationwide• Advantice Health

Losartan Potassium Tablets (Legacy) – NMBA Impurity (2019)

CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)

Class IIModerate

FDAApr 24, 2019AZ, TN• Legacy Pharmaceutical Packaging LLC

Divalproex Sodium Tablets (Major Pharmaceuticals) – Humidity Exposure (2019)

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

Class IIModerate

FDAApr 24, 2019Nationwide• MAJOR PHARMACEUTICALS

Losartan Potassium Tablets (AVKARE) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

Class IIModerate

FDAApr 24, 2019Nationwide• AVKARE Inc.

Losartan Potassium Tablets (AVKARE) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

Class IIModerate

FDAApr 24, 2019Nationwide• AVKARE Inc.

Fentanyl Citrate Injection (Akorn Inc) – Impurity Specification (2019)

Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.

FDAApr 23, 2019Nationwide• Akorn Inc

Titanium 4000 Capsule (D.B.P. Distribution) – Undeclared Ingredients (2019)

Undeclared Allergen

Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.

FDAApr 23, 2019Nationwide• D.B.P. Distribution

Antibacterial Hand Soap (Inopak Ltd) – Manufacturing Deviation (2019)

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Class IIModerate

FDAApr 22, 2019Nationwide• Inopak Ltd

INOFOAM Foaming Hand Wash (Inopak Ltd) – Manufacturing Deviation (2019)

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Class IIModerate

FDAApr 22, 2019Nationwide• Inopak Ltd

Healthcare 2000 Hand Soap (Inopak Ltd) – Manufacturing Deviation (2019)

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Class IIModerate

FDAApr 22, 2019Nationwide• Inopak Ltd

Sani-Guard Hand Sanitizer (Inopak Ltd) – Manufacturing Deviation (2019)

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Class IIModerate

FDAApr 22, 2019Nationwide• Inopak Ltd

Antibacterial Hand Soap (Inopak Ltd) – Manufacturing Deviation (2019)

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Class IIModerate

FDAApr 22, 2019Nationwide• Inopak Ltd

AQUACIL Hand Sanitizer (Inopak Ltd) – Manufacturing Deviation (2019)

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Class IIModerate

FDAApr 22, 2019Nationwide• Inopak Ltd

Losartan Potassium/HCTZ Tablet (RemedyRepack) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

Class IIModerate

FDAApr 22, 2019FL• RemedyRepack Inc.

Carvedilol Tablets (Zydus Pharmaceuticals) – Foreign Tablet Contamination (2019)

Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.

FDAApr 22, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Antibacterial Foaming Hand Wash (Inopak Ltd) – Manufacturing Deviation (2019)

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Class IIModerate

FDAApr 22, 2019Nationwide• Inopak Ltd

INODERM Antiseptic Hand Soap (Inopak Ltd) – Labeling Error (2019)

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Class IIModerate

FDAApr 22, 2019Nationwide• Inopak Ltd

Unison Hand Care Anti-Bacterial Cleaner (Inopak Ltd) – Manufacturing Deviation (2019)

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Class IIModerate

FDAApr 22, 2019Nationwide• Inopak Ltd

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