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Showing 1801–1820 of 2326 results

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Daytrana 10mg (Noven) - Patch Defect (2021)

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Class IIModerate

FDAMay 20, 2021Nationwide• Noven Pharmaceuticals Inc

Daytrana 15mg (Noven) - Patch Defect (2021)

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Class IIModerate

FDAMay 20, 2021Nationwide• Noven Pharmaceuticals Inc

Medically Minded Hand Sanitizer (Global) - Manufacturing Deviation (2021)

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Class IIModerate

FDAMay 12, 2021Nationwide• Global Sanitizers LLC

Hand Sanitizer Gel (Global Sanitizers) – Manufacturing Issues (2021)

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Class IIModerate

FDAMay 12, 2021Nationwide• Global Sanitizers LLC

Hand Sanitizer Gel (Global Sanitizers) – Manufacturing Issues (2021)

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Class IIModerate

FDAMay 12, 2021Nationwide• Global Sanitizers LLC

Hand Sanitizer Gel with Aloe (Global Sanitizers) – Manufacturing Issues (2021)

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Class IIModerate

FDAMay 12, 2021Nationwide• Global Sanitizers LLC

Lipodrene Ephedra Extract (Hi Tech Pharmaceuticals) – unapproved additive (2021)

The firm was notified by the FDA that the product contains the unapproved food additive 1,4-dimethylamylamine (DMAA).

Class IIModerate

FDAMay 12, 2021AL, AZ, CA +35 more• Hi Tech Pharmaceuticals

Vitaccino Coffee (DASH XCLUSIVE) – Undeclared Ingredients (2021)

Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine

Class IIModerate

FDAMay 11, 2021Nationwide• DASH XCLUSIVE

Metformin HCl Extended Release (Preferred) – NDMA Impurity (2021)

CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.

Class IIModerate

FDAApr 28, 2021FL, IN• Preferred Pharmaceuticals, Inc.

Muffin Tray (Bake n Show) – Foreign Objects (2021)

The firm was notified via a customer complaint that they found foreign objects in the packaging of the product.

Class IIModerate

FDAApr 19, 2021AL, AZ, CA +21 more• Genpak

Cake Tray (Bake n Show) – Foreign Objects (2021)

The firm was notified via a customer complaint that they found foreign objects in the packaging of the product.

Class IIModerate

FDAApr 19, 2021AL, AZ, CA +21 more• Genpak

Bake n Show Angel Food Tray (Genpak) – Foreign Objects (2021)

The firm was notified via a customer complaint that they found foreign objects in the packaging of the product.

Class IIModerate

FDAApr 19, 2021AL, AZ, CA +21 more• Genpak

Oven Ready Food Tray (Bake n Show) – Foreign Objects (2021)

The firm was notified via a customer complaint that they found foreign objects in the packaging of the product.

Class IIModerate

FDAApr 19, 2021AL, AZ, CA +21 more• Genpak

Pizza Cookie Tray (Bake n Show) – Foreign Objects (2021)

The firm was notified via a customer complaint that they found foreign objects in the packaging of the product.

Class IIModerate

FDAApr 19, 2021AL, AZ, CA +21 more• Genpak

Cephalexin Oral Suspension (Preferred) – impurity issue (2021)

Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin

Class IIModerate

FDAApr 12, 2021CA• Preferred Pharmaceuticals, Inc.

Flurandrenolide Ointment (Teligent) – specification failure (2021)

Failed Impurities/Degradation Specifications:

Class IIModerate

FDAApr 9, 2021Nationwide• Teligent Pharma, Inc.

PremierZen Extreme 3000 (Hyobin) – unapproved ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.

Class IIModerate

FDAApr 6, 2021Nationwide• Hyobin LLC

PremierZen Black 5000 (Hyobin) – unapproved ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.

Class IIModerate

FDAApr 6, 2021Nationwide• Hyobin LLC

Triple SupremeZen Plus (Hyobin) – unapproved ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.

Class IIModerate

FDAApr 6, 2021Nationwide• Hyobin LLC

Imperial Platinum 2000 (QMart) - Undeclared Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Class IIModerate

FDAMar 31, 2021Nationwide• QMart

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