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Showing 181–200 of 216 results

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PANCREAZE Digestive Enzyme Capsules (Vivus) – Stability Failure (2023)

Failed Stability Specifications

FDAJun 23, 2023Nationwide• Vivus, Inc.

Tranexamic Acid Tablets (AVKARE) – Conductivity Specification (2023)

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

FDAJun 13, 2023Nationwide• AVKARE LLC

Lidocaine Patch (Bryant Ranch) – Labeling Error (2023)

Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.

Class IIILow

FDAApr 20, 2023Nationwide• Bryant Ranch Prepack, Inc.

Epinephrine Kit (Focus Health Group) – Incorrect Labeling (2023)

Labeling; Incorrect NDC number on outer carton of product.

FDAMar 16, 2023Nationwide• Focus Health Group Inc

Mektovi 15mg Tablets (Pfizer) – Incorrect Expiration (2023)

Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.

FDAMar 8, 2023Nationwide• Pfizer Inc.

Evamist (Padagis) – content uniformity failure (2023)

Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.

FDAFeb 21, 2023Nationwide• Padagis US LLC

Atropine Sulfate Eye Solution (Akorn) – Failed Stability (2023)

Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.

FDAJan 30, 2023Nationwide• Akorn, Inc.

Tranexamic Acid Injection (AuroMedics) – metal contamination (2022)

Presence of Particulate Matter: Piece of metal found in a vial

FDASep 26, 2022Nationwide• AuroMedics Pharma 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

Tacrolimus Ointment (Glenmark) – Packaging Defect (2022)

Defective Container: Tube split from side seam

FDAJul 11, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

Aspirin Dipyridamole Capsules (Glenmark) – Capsule Breakage (2022)

Failed Tablet/Capsule Specification : Capsule breakage

FDAJun 29, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

Old Fashion Strawberry Creme Cake (Select Bakery) – Undeclared Soy (2022)

Undeclared Soy

FDAJun 22, 2022GA, NC, SC• Select Bakery Inc.

Old Fashion Orange Creme Cake (Select Bakery) – Undeclared Soy (2022)

Undeclared Soy

FDAJun 22, 2022GA, NC, SC• Select Bakery Inc.

Old Fashion Pineapple Creme Cake (Select Bakery) – Undeclared Soy (2022)

Undeclared Soy

FDAJun 22, 2022GA, NC, SC• Select Bakery Inc.

Peanut Butter Delight (Select Bakery) – Undeclared Ingredients (2022)

Undeclared Soy and Red #40

FDAJun 22, 2022GA, NC, SC• Select Bakery Inc.

Select Bakery Cheerwine (Select Bakery Inc) – undeclared ingredients (2022)

Undeclared soy, Red #40 & sulfites

FDAJun 22, 2022GA, NC, SC• Select Bakery Inc.

Old Fashion Chocolate Creme Cake (Select Bakery) – Undeclared Soy (2022)

Undeclared Soy

FDAJun 22, 2022GA, NC, SC• Select Bakery Inc.

Walnut Brownie (Select Bakery) – Undeclared Ingredients (2022)

Undeclared Soy and Red #40

FDAJun 22, 2022GA, NC, SC• Select Bakery Inc.

Gourmet Banana Nut Pound Cake (Select Bakery) – Undeclared Soy (2022)

Undeclared soy

FDAJun 22, 2022GA, NC, SC• Select Bakery Inc.

Old Fashion Walnut Creme Cake (Select Bakery) – Undeclared Allergens (2022)

Undeclared Soy and Sulfites

FDAJun 22, 2022GA, NC, SC• Select Bakery Inc.

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