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Phenylephrine HCl IV Bag (Denver Solutions) – manufacturing deviation (2023)

CGMP DEVIATIONS

Class IIModerate

FDAFeb 21, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Phenylephrine HCl IV Bag (Denver Solutions) – manufacturing deviation (2023)

CGMP DEVIATIONS

Class IIModerate

FDAFeb 21, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Rao's Roasted Peppers (Sunny Dell) – Undeclared pine nuts (2023)

Undeclared Allergen

May contain undeclared pine nuts

Class IIModerate

FDAFeb 21, 2023IN, NJ• Sunny Dell, Inc.

Kirkland Cold Brew Coffee (Berner Foods) – Foreign metal material (2023)

Foreign material, metal

Class IIModerate

FDAFeb 17, 2023AZ, CA, CO +10 more• Berner Foods Inc.

Stainless Steel Water Bottle (Bindle) – Lead weld hazard (2023)

Water bottle has a cup with a screw cap attached by a weld that has been found to leach lead.

Class IIModerate

FDAFeb 17, 2023Nationwide• BINDLE BOTTLE

Sheetz Ham Deli Sandwich – Undeclared sesame (2023)

Undeclared Allergen

Product may contain undeclared sesame

Class IIModerate

FDAFeb 16, 2023IN, MD, NC +4 more• Sheetz Distribution Services, L.L.C.

Sheetz Turkey Deli Sandwich – Undeclared sesame (2023)

Undeclared Allergen

Product may contain undeclared sesame.

Class IIModerate

FDAFeb 16, 2023IN, MD, NC +4 more• Sheetz Distribution Services, L.L.C.

Chocolate Peanut Butter Cereal (Catalina Snacks) – Metal Contamination (2023)

Foreign material, metal

Class IIModerate

FDAFeb 15, 2023AZ, CA, CO +18 more• Catalina Snacks

Maple Waffle Cereal (Catalina Snacks) – Metal Contamination (2023)

Foreign material, metal

Class IIModerate

FDAFeb 15, 2023AZ, CA, CO +18 more• Catalina Snacks

Testosterone Cypionate Injection (Azurity) – Crystal Redissolution Issue (2023)

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Class IIModerate

FDAFeb 15, 2023Nationwide• Azurity Pharmaceuticals, Inc.

Warfarin Sodium Tablets (Rising Pharmaceuticals) – Impurities Spec Failure (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 15, 2023Nationwide• RISING PHARMACEUTICALS

Honey Graham Cereal (Catalina Snacks) – Foreign metal material (2023)

Foreign material, metal

Class IIModerate

FDAFeb 15, 2023AZ, CA, CO +18 more• Catalina Snacks

Spicy Kick Snack Mix (Catalina Snacks) – Metal Contamination (2023)

Foreign material, metal

Class IIModerate

FDAFeb 15, 2023AZ, CA, CO +18 more• Catalina Snacks

Fruit Cereal (Catalina Snacks) – Metal Contamination (2023)

Foreign material - metal.

Class IIModerate

FDAFeb 15, 2023AZ, CA, CO +18 more• Catalina Snacks

Creamy Ranch Snack Mix (Catalina Snacks) – Metal Contamination (2023)

Foreign material, metal

Class IIModerate

FDAFeb 15, 2023AZ, CA, CO +18 more• Catalina Snacks

Cheddar Snack Mix (Catalina Snacks) – Metal Contamination (2023)

Foreign material, metal

Class IIModerate

FDAFeb 15, 2023AZ, CA, CO +18 more• Catalina Snacks

Shichimi Togarashi Spice (Wismettac) – Undeclared Sesame (2023)

Product was found to contain sesame that were not declared on the ingredient label. Potential for product mix up, so product i being recalled out of an abundance of caution

Class IIModerate

FDAFeb 14, 2023Nationwide• Wismettac Asian Foods, Inc.

MSM Nasal Spray (Pharmedica USA) – CGMP Deviation (2023)

CGMP Deviations

Class IIModerate

FDAFeb 14, 2023Nationwide• Pharmedica USA, LLC

Chili Pepper Powder (Wismettac) – Undeclared Sesame (2023)

Product was found to contain sesame that were not declared on the ingredient label.

Class IIModerate

FDAFeb 14, 2023Nationwide• Wismettac Asian Foods, Inc.

Winter Mint Chocolate Protein (Niagara) – Processing Concern (2023)

The recalled product did not meet the pre-kill step processing specifications and has the potential to be spoiled.

Class IIModerate

FDAFeb 14, 2023CA• Niagara Bottling

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