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Showing 541–548 of 548 results

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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

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

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

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

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

Ketorolac Tromethamine Injection (Hospira) – crystallization risk (2015)

Crystallization; identified as calcium salt of Ketorolac

Class IIModerate

FDAJun 30, 2015Nationwide• Hospira Inc.

Ketorolac Tromethamine Injection (Hospira) – crystallization risk (2015)

Crystallization; identified as calcium salt of Ketorolac

Class IIModerate

FDAJun 30, 2015Nationwide• Hospira Inc.

Blue Male Enhancement Pill (Menz Club) – Unapproved Ingredient (2012)

Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug

FDAMar 10, 2012UT• The Menz Club, LLC

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