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Sodium Chloride Ophthalmic Ointment (Akorn) – Particulate Matter (2020)

Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.

Class IIILow

FDAFeb 21, 2020Nationwide• Akorn, Inc.

Mesalamine Tablets (Teva) – Dissolution Specification Failure (2020)

Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.

Class IIModerate

FDAFeb 20, 2020Nationwide• Teva Pharmaceuticals USA

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Sodium Chloride Ophthalmic Ointment (Akorn) – Particulate Matter (2020)

Mesalamine Tablets (Teva) – Dissolution Specification Failure (2020)

Desoximetasone Topical Spray (Lupin) – Impurity Specification Failure (2020)

Peanut Clusters (Natural Grocers) – undeclared allergens (2020)

Almond Clusters (Natural Grocers) – undeclared allergens (2020)

D. Tox Shake Mix (Lifetime Fitness) – unapproved herbicide (2020)

D. Tox Shake Mix (Lifetime Fitness) – unapproved herbicide (2020)

Potassium Chloride Tablets (Strides) – Tablet Size Issue (2020)

Memantine Capsules (Lupin) – Dissolution Specification Failure (2020)

Tramadol Tablets (Golden State) – Incorrect Package Insert (2020)

Frovatriptan Tablets (Par) – Incorrect Expiration Date (2020)

Glycopyrrolate Injection (AuroMedics) – Benzaldehyde Impurity (2020)

Phenytoin Suspension (Taro) – Resuspension Problems (2020)

Desmopressin Tablets (American Health) – Missing Desiccant (2020)

Desmopressin Tablets (American Health) – Missing Desiccant (2020)

Organic Extra Virgin Coconut Oil (Natural Grocers) – High mold (2020)

Organic Extra Virgin Coconut Oil (Natural Grocers) – High mold (2020)

Caduet Tablets (Pfizer) – Defective Container 10/10mg (2020)

Caduet Tablets (Pfizer) – Defective Container 10/20mg (2020)

Extra Strength Acetaminophen (Contract Pharmacal) – Foreign Tablet Mix (2020)