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Showing 2541–2560 of 29086 results

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Fanta Orange (United Packers) – foreign material (2023)

Potential foreign material

Class IIModerate

FDANov 6, 2023AL, FL, MS• United Packers, LLC

Diet Coke (United Packers) – foreign material (2023)

Potential foreign material

Class IIModerate

FDANov 6, 2023AL, FL, MS• United Packers, LLC

Le Croissant Turkey & Cheddar (Hearn Kirkwood) – undeclared milk/soy (2023)

Undeclared Milk

Undeclared milk and soy

Class IIModerate

FDANov 3, 2023AL, CT, DE +13 more• The Coastal Companies DBA Hearn Kirkwood

Telera Bread (California Bread Co.) – undeclared milk (2023)

Undeclared Allergen

Undeclared allergen; milk

Class IIModerate

FDANov 3, 2023CA• California Bread Co.

Breakfast Sandwich Bacon Egg & Cheddar (Hearn Kirkwood) – undeclared milk/soy (2023)

Undeclared Milk

Undeclared milk and soy

Class IIModerate

FDANov 3, 2023AL, CT, DE +13 more• The Coastal Companies DBA Hearn Kirkwood

AFTERBURN Whey Protein Bar (Doctors Scienfic Organica) – foreign material (2023)

Foreign material including disposable hairnet, shrink wrap and parchment paper.

Class IIModerate

FDANov 3, 2023Nationwide• Doctors Scienfic Organica

Le Croissant Ham & Swiss (Hearn Kirkwood) – undeclared milk/soy (2023)

Undeclared Milk

Undeclared milk and soy

Class IIModerate

FDANov 3, 2023AL, CT, DE +13 more• The Coastal Companies DBA Hearn Kirkwood

Milled Brown Flax MBF9 (Scoular Grain) – foreign object (2023)

Foreign object (plastic)

Class IIModerate

FDANov 2, 2023TX• Scoular Grain Co

Milled Golden Flax MGDF (Scoular Grain) – foreign object (2023)

Foreign object (plastic)

Class IIModerate

FDANov 2, 2023TX• Scoular Grain Co

Trospium Chloride Capsules (Padagis) – Capsule Defects (2023)

Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

Class IIModerate

FDANov 1, 2023Nationwide• Padagis US LLC

Paroxetine Tablets 40mg (Apotex) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 1, 2023Nationwide• Apotex Corp.

Paroxetine Tablets 30mg (Apotex) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 1, 2023Nationwide• Apotex Corp.

Paroxetine Tablets 10mg (Apotex) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 1, 2023Nationwide• Apotex Corp.

Paroxetine Tablets 20mg (Apotex) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 1, 2023Nationwide• Apotex Corp.

Probiotic Tri-Blend (Abbott) – unapproved drug (2023)

Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive

Class IIModerate

FDAOct 31, 2023AL, AZ, AR +38 more• Abbott Laboratories

Phenytoin Sodium Capsules 100mg (Amneal) – failed dissolution (2023)

Failed Dissolution Specifications

Class IIModerate

FDAOct 27, 2023Nationwide• Amneal Pharmaceuticals of New York, LLC

Crush Orange Soda (Pepsi) – plastic contamination (2023)

foreign material - plastic

Class IIModerate

FDAOct 27, 2023MN• Pepsi Beverages, LLC

Ranolazine Tablets 500mg (Glenmark) – failed dissolution (2023)

Failed Dissolution Specifications: Out of specification for dissolution.

Class IIModerate

FDAOct 23, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Nutricia KetcoCal 4:1 LQ Unflavored (Nutricia) – Incorrect Packaging (2023)

Incorrect product in packaging

Class IIModerate

FDAOct 20, 2023AL, CA, CO +18 more• Nutricia North America

Equate Hand Sanitizer (Omega & Delta) – Potency Issue (2023)

Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Class IIModerate

FDAOct 20, 2023IN, PR• Omega & Delta Co., Inc.

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