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Showing 5781–5800 of 15081 results

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QUIK-CARE Hand Sanitizer (Ecolab) – Incorrect Alcohol (2019)

Undeclared Allergen

Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.

FDAMay 10, 2019Nationwide• Ecolab Inc

Anastrozole Tablets (American Health) – Cross Contamination (2019)

GMP Deviations: Potential cross contamination due to cleaning procedure failure.

Class IIModerate

FDAMay 9, 2019Nationwide• American Health Packaging

Anastrozole Tablets (American Health) – Cross Contamination (2019)

GMP Deviations: Potential cross contamination due to cleaning procedure failure.

Class IIModerate

FDAMay 9, 2019Nationwide• American Health Packaging

The Beast (Stiff Boy) – Undeclared Sildenafil (2019)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.

FDAMay 6, 2019Nationwide• Stiff Boy LLC

Pramipexole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Anastrozole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Ultra DHA Fish Oil (Barlean's) – Undeclared sulfites (2019)

Undeclared Allergen

Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.

FDAMay 6, 2019Nationwide• Barlean's Llc

Fish Oil Omega-3 (Barlean's) – Undeclared sulfites (2019)

Undeclared Allergen

Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.

FDAMay 6, 2019Nationwide• Barlean's Llc

Anastrozole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

MethylPREDNISolone Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Pramipexole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Senna Syrup (Geritrex) – Odor and Taste Issue (2019)

Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

Class IIModerate

FDAMay 6, 2019Nationwide• Geritrex, LLC

Pramipexole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

MethylPREDNISolone Tablets (Zydus) – Cross Contamination Risk (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Ultra EPA-DHA Fish Oil (Barlean's) – Undeclared sulfites (2019)

Undeclared Allergen

Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.

FDAMay 6, 2019Nationwide• Barlean's Llc

Pramipexole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

MethylPREDNISolone Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Pramipexole Tablets (Zydus) – Cross Contamination Risk (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

MethylPREDNISolone Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Pramipexole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

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