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FIRST Omeprazole Suspension 2mg/mL (CutisPharma) – Labeling Error (2016)

Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL

Class IIILow

FDAOct 20, 2016Nationwide• CutisPharma, Inc.

FIRST Omeprazole Suspension 2mg/mL (CutisPharma) – Labeling Error (2016)

Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL

Class IIILow

FDAOct 20, 2016Nationwide

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FIRST Omeprazole Suspension 2mg/mL (CutisPharma) – Labeling Error (2016)

FIRST Omeprazole Suspension 2mg/mL (CutisPharma) – Labeling Error (2016)

Invokamet (Janssen) – Incorrect Package Insert (2016)

Ceftriaxone Injection 1g (Sandoz) – Missing Label (2016)

Duloxetine Capsules 30mg (Inventia Healthcare) – Capsule Shell Defect (2016)

HCG (Town and Country) – Subpotent Drug (2016)

Olanzapine Tablets (Dr. Reddy's) – Impurity Specification (2016)

AHP NIFEdipine Capsules (Amerisource) – Foreign Tablets (2016)

Succinylcholine Chloride (Pharmedium) – Sterility Concerns (2016)

Testosterone Cypionate (Pharm D) – Incorrect Oil Description (2016)

HCG-Vitamin B12 (Pharm D) – Strength Label Error (2016)

NIFEdipine Capsules (Actavis) – Foreign Tablets (2016)

Dipyridamole Tablets (Boehringer) – Foreign Tablets (2016)

Persantine (Boehringer) – Foreign Tablets (2016)

Travoprost Solution (Par) – Sterility Risk (2016)

MealPlex (Professional Botanicals) – undeclared milk allergen (2016)

Prednisone Tablets (West-Ward) – Underweight Tablet (2016)

Phenobarbital Tablets (West-Ward) – Dissolution Failure (2016)

Slimming Herbs Drops (Infiniti Creations) – misbranding risk (2016)

HCG ASAP Drops (Infiniti Creations) – misbranding risk (2016)