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Gabapentin Oral Solution (Akorn) – CGMP Manufacturing Deviation (2017)

CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.

FDADec 15, 2017Nationwide• Akorn Inc

Auryxia Tablets (Keryx) – Foreign Substance Risk (2017)

Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.

Class IIILow

FDADec 12, 2017Nationwide• Keryx Biopharmaceuticals, Inc.

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Gabapentin Oral Solution (Akorn) – CGMP Manufacturing Deviation (2017)

Auryxia Tablets (Keryx) – Foreign Substance Risk (2017)

BluePrint Beet Blast (Hain Celestial) – incorrect label (2017)

Enoxaparin Sodium Injection (Sanofi-Aventis) – Label Strength Error (2017)

Publix Diced Hash Brown Potatoes (McCain Foods) – Foreign Object (2017)

Bull Capsules (BYL Solutions) – Undeclared Sildenafil (2017)

Penicillin V Potassium Solution (Teva) – Impurity Specifications (2017)

Duloxetine Capsules (Lupin) – Dissolution Specification (2017)

Soft Ricotta (Clover Hill Dairy) – Manufacturing Deviation (2017)

AI Enzymes (Pure Encapsulations) – Undeclared Sulfites (2017)

Systemic Enzyme Complex (Pure Encapsulations) – Undeclared Sulfites (2017)

Gluten Free Panko Breadcrumbs (Ian's) – Potential Beetle Exposure (2017)

Gluten Free Italian Breadcrumbs (Ian's) – Potential Beetle Exposure (2017)

Fiore Di Latte Mozzarella (Maple Hill Creamery) – Premature Spoilage (2017)

Isradapine 2.5 mg Capsules (Elite Labs) – impurity specifications (2017)

Fluconazole Injection 2 mg/mL (Renaissance) – superpotent (2017)

Bayer Chewable Aspirin 81 mg (Bayer) – stability failure (2017)

Cranberry & Nuts Trail Mix (Happy Belly) - Incorrect label (2017)

Deluxe Mixed Nuts (Happy Belly) - Incorrect label (2017)

Dexamethasone Sodium Phosphate 4 mg/mL (West-Ward) – impurity concerns (2017)