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Showing 5681–5700 of 9561 results

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Medroxyprogesterone Injection (Western Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 19, 2015Nationwide• Western Drug

Wilson's Nasal Irrigation Solution (Western Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 19, 2015Nationwide• Western Drug

Ascorbic Acid Injection (Western Drug) – sterility concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 19, 2015Nationwide• Western Drug

Tri-Mix LOW ED Injection (Western Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 19, 2015Nationwide• Western Drug

Hydroxocobalamin Injection (Western Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 19, 2015Nationwide• Western Drug

T.C.A Acid Solution (Western Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 19, 2015Nationwide• Western Drug

AMP50/B121MG Complex Injection (Western Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 19, 2015Nationwide• Western Drug

Hydroxocobalamin Injection (Western Drug) – Sterility Issue (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 19, 2015Nationwide• Western Drug

Marcaine 0.24%/Ethanol 4% Injection (Western Drug) – sterility concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 19, 2015Nationwide• Western Drug

Tev-Tropin Injection (Western Drug) – sterility concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 19, 2015Nationwide• Western Drug

Pea Protein Powder (Prinova) – Undeclared Soy (2015)

Undeclared Allergen

Undeclared Soy on label. RFR was generated by a customer who used the Pea Protein in a blended product that claims to be soy free. The Pea Protein tested positive for soy allergen.

FDAOct 16, 2015Nationwide• Prinova US LLC

Screenses Color Sunscreen (Sesderma) – Manufacturing Quality Issue (2015)

cGMP Deviations; product does not comply with cGMP requirements

Class IIModerate

FDAOct 15, 2015CO, FL, GA +1 more• Sesderma, SL

Repaskin 50 Body Lotion (Sesderma) – Manufacturing Quality Issue (2015)

cGMP Deviations; product does not comply with cGMP requirements

Class IIModerate

FDAOct 15, 2015CO, FL, GA +1 more• Sesderma, SL

Repaskin 30 Sunscreen (Sesderma) – Manufacturing Quality Issue (2015)

cGMP Deviations; product does not comply with cGMP requirements

Class IIModerate

FDAOct 15, 2015CO, FL, GA +1 more• Sesderma, SL

Glazed Doughnut Holes (Krispy Kreme) – Glass Contamination (2015)

Finished product may contain foreign matter (glass).

Class IIModerate

FDAOct 15, 2015GA• Krispy Kreme Doughnut Corporation

Screenses Color Sunscreen (Sesderma) – Manufacturing Quality Issue (2015)

cGMP Deviations; product does not comply with cGMP requirements

Class IIModerate

FDAOct 15, 2015CO, FL, GA +1 more• Sesderma, SL

Repaskin 50 Facial Sunscreen (Sesderma) – Manufacturing Quality Issue (2015)

cGMP Deviations; product does not comply with cGMP requirements

Class IIModerate

FDAOct 15, 2015CO, FL, GA +1 more• Sesderma, SL

Lemon Filled Doughnuts (Krispy Kreme) – Glass Contamination (2015)

Finished product may contain foreign matter (glass).

Class IIModerate

FDAOct 15, 2015GA• Krispy Kreme Doughnut Corporation

Original Glazed Doughnuts (Krispy Kreme) – glass contamination (2015)

Finished product may contain foreign matter (glass).

Class IIModerate

FDAOct 15, 2015GA• Krispy Kreme Doughnut Corporation

Glazed Doughnuts with Filling (Krispy Kreme) – Glass Contamination (2015)

Finished product may contain foreign matter (glass).

Class IIModerate

FDAOct 15, 2015GA• Krispy Kreme Doughnut Corporation

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