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Showing 4721–4740 of 29086 results

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Children's Botanicals Daytime (P&G) – unapproved process (2022)

Acidified/Low Acid dietary supplement with no approved process.

Class IIModerate

FDAJul 12, 2022AL, AK, AZ +42 more• The Procter & Gamble Company

ZzzQuil Liquid Melatonin Syrup (P&G) – unapproved process (2022)

Acidified/Low Acid dietary supplement with no approved process.

Class IIModerate

FDAJul 12, 2022AL, AK, AZ +42 more• The Procter & Gamble Company

Children's Botanicals Combo (P&G) – unapproved process (2022)

Acidified/Low Acid dietary supplement with no approved process.

Class IIModerate

FDAJul 12, 2022AL, AK, AZ +42 more• The Procter & Gamble Company

ZzzQuil Pediatric Melatonin Syrup (P&G) – unapproved process (2022)

Acidified/Low Acid dietary supplement with no approved process.

Class IIModerate

FDAJul 12, 2022AL, AK, AZ +42 more• The Procter & Gamble Company

Lorazepam Injection 2mg (Hikma) – Compound Degradation (2022)

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Class IIModerate

FDAJul 11, 2022Nationwide• Hikma Pharmaceuticals USA Inc.

Lorazepam Injection 4mg (Hikma) – Impurity Detection (2022)

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Class IIModerate

FDAJul 11, 2022Nationwide• Hikma Pharmaceuticals USA Inc.

Lorazepam Injection 2mg (Hikma) – Impurity Concerns (2022)

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Class IIModerate

FDAJul 11, 2022Nationwide• Hikma Pharmaceuticals USA Inc.

Ativan Injection (Hikma) – Compound Instability (2022)

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Class IIModerate

FDAJul 11, 2022Nationwide• Hikma Pharmaceuticals USA Inc.

Naftifine Hydrochloride Gel (Tolmar) – Impurity Specification (2022)

Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time

Class IIModerate

FDAJul 11, 2022IN, KY• Tolmar, Inc.

Lemon Muffins (Portland Specialty Baking) – Packaging Issue (2022)

Plastic material.

Class IIModerate

FDAJul 7, 2022CA, ID, IN +1 more• Portland Specialty Baking LLC

Strawberry Punch Snow Cone (Clear American) – Undeclared Coconut (2022)

The product may contain trace amounts of coconut, which is not declared on the labeling. Laboratory analysis was unable to detect any coconut allergen, however the firm has decided to recall out of an abundance of caution.

Class IIModerate

FDAJul 7, 2022AZ, CA, IL +12 more• Refresco Beverages US Inc

Aripiprazole Tablets 20mg (Apotex) – Dissolution Specifications (2022)

Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.

Class IIModerate

FDAJul 7, 2022Nationwide• Apotex Corp.

Cheesecake Bites Lemon (Chuckanut Bay) – Undeclared Soy (2022)

Undeclared Soy Lecithin. Label declares Chocolate Compound (Sunflower Lecithin) instead of Soy Lecithin.

Class IIModerate

FDAJul 6, 2022AL, CA, CO +11 more• Chuckanut Bay Foods LLC

Espresso Cheesecake Bites (Chuckanut Bay) – undeclared soy (2022)

Undeclared Soy Lecithin. Label declares Chocolate Compound (Sunflower Lecithin) instead of Soy Lecithin.

Class IIModerate

FDAJul 6, 2022AL, CA, CO +11 more• Chuckanut Bay Foods LLC

Chocolate Coconut Cheesecake Bites (Chuckanut Bay) – Undeclared Soy (2022)

Undeclared Soy Lecithin. Label declares Chocolate Compound (Sunflower Lecithin) instead of Soy Lecithin.

Class IIModerate

FDAJul 6, 2022AL, CA, CO +11 more• Chuckanut Bay Foods LLC

Sharis Strawberry Cheesecake Bites (Chuckanut Bay) – Undeclared Soy (2022)

Undeclared Soy Lecithin. Label declares Sunflower Lecithin instead of Soy Lecithin.

Class IIModerate

FDAJul 6, 2022AL, CA, CO +11 more• Chuckanut Bay Foods LLC

Smoked Clams (Bumble Bee) – PFAS Contamination (2022)

Detectable levels of Per- and polyfluoroalkyl substances (PFAS).

Class IIModerate

FDAJul 6, 2022AZ, CA, DE +10 more• Bumble Bee Foods, LLC

Chocolate Covered Cheesecake Bites (Chuckanut Bay) – Undeclared Soy (2022)

Undeclared Soy Lecithin. Label declares Sunflower Lecithin instead of Soy Lecithin.

Class IIModerate

FDAJul 6, 2022AL, CA, CO +11 more• Chuckanut Bay Foods LLC

Dipped Cheesecake Bites Chocolate (Chuckanut Bay) – undeclared soy (2022)

Undeclared Soy Lecithin. Label declares Sunflower Lecithin instead of Soy Lecithin.

Class IIModerate

FDAJul 6, 2022AL, CA, CO +11 more• Chuckanut Bay Foods LLC

Dipped Cheesecake Bites Lemon (Chuckanut Bay) – undeclared soy (2022)

Undeclared Soy Lecithin. Label declares Sunflower Lecithin instead of Soy Lecithin.

Class IIModerate

FDAJul 6, 2022AL, CA, CO +11 more• Chuckanut Bay Foods LLC

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