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Showing 601–620 of 3363 results

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OxyTOCIN IV Solution (QuVa Pharma) – Incorrect Formulation (2022)

Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).

FDASep 20, 2022Nationwide• QuVa Pharma, Inc.

Clonidine Hydrochloride Tablets (UNICHEM) – Product Mix-up (2022)

Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

FDASep 19, 2022Nationwide• UNICHEM PHARMACEUTICALS USA INC

Coconut Jam (Fila Manila) – Undeclared Gluten (2022)

Undeclared Gluten

Undeclared gluten

FDASep 19, 2022IN, NV• Fila Manila Corporation

Turkey Gravy Mix (Karlsburger) – Undeclared Gluten (2022)

Undeclared Allergen

undeclared non-wheat gluten, product labeled gluten-free

FDASep 19, 2022KS, MN, NE +1 more• Karlsburger Foods, Inc.

Beef Gravy Mix (Karlsburger) – Undeclared Gluten (2022)

Undeclared Allergen

undeclared non-wheat gluten, product labeled gluten-free

FDASep 19, 2022KS, MN, NE +1 more• Karlsburger Foods, Inc.

Xolegel Ketoconazole Gel (ALMIRALL) – Viscosity Specification (2022)

Failed Viscosity specification: Slightly higher OOS results obtained for viscosity

FDASep 16, 2022Nationwide• ALMIRALL, LLC

Phytonadione Injectable Emulsion (Dr. Reddy's) – Aluminum Content (2022)

Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

FDASep 14, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Antibacterial Foaming Wash (Woodbine) – Incorrect Label (2022)

Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.

FDAAug 30, 2022NC• Woodbine Products Co Inc

Haiyue Food Preserved Vegetable (XIUMIN LIN) – Cyclamate (2022)

Contains Cyclamate

FDAAug 29, 2022FL, IN, NY +1 more• XIUMIN LIN

G-PREPROTEIN Liquid Supplement (Kramer Novis) – Unusual Appearance (2022)

Physical appearance of bottle of G-Pre Protein was atypical. Once opened, unusual odor was noticed and atypical bubbles were present.

FDAAug 25, 2022PR• Novis PR, LLC dba Kramer Novis

ClomiPRAMINE Hydrochloride Capsules (Leading Pharma) – Superpotent Drug (2022)

Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules

FDAAug 23, 2022Nationwide• Leading Pharma, LLC

Mountain Dew Major Melon Zero (Pepsico) – packaging mismatch (2022)

The outer wraps match the liquid in the can (Zero Sugar - Mountain Dew Major Melon) however the primary package (can) is incorrect (Full Sugar Mountain Dew Major Melon). Product inside can matches the product/nutritional panel on the point-of-sale outer container wrap.

FDAAug 17, 2022Nationwide• Pepsico Inc

Samoon Pita Bread (Alida's Bakery) – undeclared soy (2022)

Undeclared soy lecithin. The canola oil used to grease pans was found to contain soy lecithin.

FDAAug 16, 2022IN, WA• Alida's Bakery LLC

Saoka Pita Bread (Alida's Bakery) – undeclared soy (2022)

Undeclared soy lecithin. The canola oil used to grease pans was found to contain soy lecithin.

FDAAug 16, 2022IN, WA• Alida's Bakery LLC

Wheat Saoka Pita Bread (Alida's Bakery) – undeclared soy (2022)

Undeclared soy lecithin. The canola oil used to grease pans was found to contain soy lecithin.

FDAAug 16, 2022IN, WA• Alida's Bakery LLC

Sambar Coconut Onion Soup (Priyems) – Undeclared Wheat Starch (2022)

Undeclared Gluten

undeclared wheat starch sub-ingredient found in the asafoetida used in the products

FDAAug 8, 2022CT, DE, IL +12 more• Yem Foods LLC

Lemon Pickle (Priyems) – Undeclared Wheat Starch (2022)

Undeclared Gluten

undeclared wheat starch sub-ingredient found in the asafoetida used in the products

FDAAug 8, 2022CT, DE, IL +12 more• Yem Foods LLC

Timolol Maleate Eye Solution (Akorn) – Unknown Impurity (2022)

Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.

FDAAug 8, 2022Nationwide• Akorn, Inc

Mango Pickles (Priyems) – Undeclared Wheat Starch (2022)

Undeclared Gluten

undeclared wheat starch sub-ingredient found in the asafoetida used in the products

FDAAug 8, 2022CT, DE, IL +12 more• Yem Foods LLC

Sambar Spicy Lentil Soup (Priyems) – Undeclared Wheat Starch (2022)

Undeclared Gluten

undeclared wheat starch sub-ingredient found in the asafoetida used in the products

FDAAug 8, 2022CT, DE, IL +12 more• Yem Foods LLC

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