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Showing 621–640 of 3363 results

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Acetaminophen 500 mg Extra Strength (Akron Pharma) – Missing Imprint (2022)

Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

FDAAug 4, 2022Nationwide• Akron Pharma, Inc.

Acetaminophen 325 mg Tablets (Akron Pharma) – Missing Imprint (2022)

Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

FDAAug 4, 2022Nationwide• Akron Pharma, Inc.

Nighttime Sleep-Aid (LNK International) – Incorrect Labeling (2022)

Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

Class IIILow

FDAAug 4, 2022Nationwide• LNK International, Inc.

Vitamin Herb Blend (Eclectic Institute) – Ingredient Mislabeling (2022)

Product's ingredients names such as Oregon Grape, Cayenne Root, and Ginger Fruit and their quantities were not listed correctly in the Supplement Facts panel.

FDAAug 3, 2022Nationwide• Eclectic Institute Inc

Zynrelef (Heron Therapeutics) – Defective Syringe (2022)

Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit

FDAAug 2, 2022Nationwide• HERON THERAPEUTICS, INC.

Azacitidine Injection (Amerisource) – Subpotent Drug (2022)

Subpotent Drug

FDAJul 27, 2022Nationwide• Amerisource Health Services LLC

Azacitidine Injection (Teva) – Subpotent Medication (2022)

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

FDAJul 22, 2022IN, OH• Teva Pharmaceuticals USA Inc

PICS Ground Cinnamon (International Spice) – Mislabeled Product (2022)

Cumin mislabeled as cinnamon

FDAJul 21, 2022IN, MA• Gourmet Spice LLC dba International Spice

Lamotrigine Tablets (AVKARE) – Strength Labeling Error (2022)

Labeling: Label Error on Declared Strength

FDAJul 20, 2022Nationwide• AVKARE Inc.

Tacrolimus Ointment (Glenmark) – Packaging Defect (2022)

Defective Container: Tube split from side seam

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

Crest 3D White Toothpaste (Procter & Gamble) – Labeling Error (2022)

Labeling: Missing label: the product tube was missing a label and contained a different formulation.

FDAJul 8, 2022WA• The Procter & Gamble Company

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

Failed Tablet/Capsule Specification : Capsule breakage

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

Juice Beauty SPF 8 Lip Moisturizer (Eco Lips) – Failed Dissolution (2022)

Failed Dissolution Specifications

FDAJun 29, 2022CA• Eco Lips, Inc

Juice Beauty SPF 8 Lip Moisturizer (Eco Lips) – Dissolution Failure (2022)

Failed Dissolution Specifications

FDAJun 29, 2022CA• Eco Lips, Inc

HyVee Oven Baked Beans (Hy-Vee) – potassium sorbate excess (2022)

Baked bean product contains excessive amount of potassium sorbate

FDAJun 28, 2022IL, IN, IA +6 more• Hy-Vee, Inc. dba Hy-Vee Fresh Commissary

GNC Vitamin B-6 Tablets (GNC) – incorrect capsule color (2022)

The firm was notified by a customer that the bottle contains green and white capsules instead of the usual white round tablets. They contacted their manufacturer to investigate the issue and the manufacture stated that there was a problem at the filling line. Bottles labeled as Vitamin B6 actually contained Pycnogenol.

FDAJun 27, 2022Nationwide• General Nutrition Inc

Simply Nature Organic Spring Mix (Dole) – hairy nightshade risk (2022)

Potential to contain hairy nightshade.

FDAJun 25, 2022IL, IN, OH +1 more• Dole Fresh Vegetables 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.

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

Undeclared Soy

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

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