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Vega One Double Chocolate Bar (Sequel Naturals) – Undeclared Milk (2013)

Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction.

Class IHigh

FDAJun 7, 2013Nationwide• Sequel Naturals Ltd

Vecuronium Bromide (Sagent) – Manufacturing Deviation (2013)

CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.

Class IIModerate

FDAJun 7, 2013

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Vega One Double Chocolate Bar (Sequel Naturals) – Undeclared Milk (2013)

Vecuronium Bromide (Sagent) – Manufacturing Deviation (2013)

Sodium Chloride Injection (Hospira) – Potential Leak (2013)

Target-Mins Iron Supplement (Country Life) – Packaging Hazard (2013)

Parsel Plus (Novartis) – Unsealed Pouches (2013)

Excedrin Migraine (Novartis) – Unsealed Pouches (2013)

Excedrin Extra Strength (Novartis) – Unsealed Pouches (2013)

Natural Whey Power (NatureMost) – Undeclared Allergens (2013)

Natural Whey Power (NatureMost) – Undeclared Allergens (2013)

Cleocin Phosphate (Pharmacia & Upjohn) – Glass Delamination (2013)

Ethambutol Tablets (West-Ward) – Surface Defect (2013)

Fentanyl Transdermal System (Actavis) – Impurity Specifications (2013)

Prempro (Pfizer) – Failed Dissolution Specs (2013)

Prempro (Pfizer) – Failed Dissolution Specs (2013)

Calcium Chloride Injection (Abrams Royal) – Non-Sterile (2013)

Norpace CR (Pfizer) – Dissolution Failure (2013)

Cefazolin Injection (Sandoz) – Sterility Risk (2013)

Technetium Tc 99m Kit (Pharmalucence) – Particulate Matter (2013)

Wholly Immune Powder (Allergy Research) – Undeclared Soy (2013)

Dexamethasone Sodium Phosphate 6 mg/ml Injection (Olympia Pharmacy) – Sterility Concerns (2013)