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Showing 26841–26860 of 29086 results

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Proplete Nutrition (Pentec) – sterility uncertainty (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Ranitidine Syrup (Actavis) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; "Related Compound C"

Class IIModerate

FDAMay 15, 2013Nationwide• Actavis South Atlantic LLC

Dr. Larry's Tranquility Supplement (Health & Beyond) – unapproved drugs (2013)

Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)

Class IIModerate

FDAMay 15, 2013CA, FL, HI +5 more• Health & Beyond

Proplete Nutrition (Pentec) – sterility uncertainty (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Proplete 70+ KG (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

IDPN Dialysate Solution (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Baxter LL Bag 1% Amino Acids (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Proplete 40-44 KG (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Baxter LL Bag 1% Amino Acids (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Baxter Ultrabag 1.5% Amino Acids (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Enzyme Solutions Supplement (Enzyme Formulations) – Labeling Error (2013)

Enzymes Formulations Inc. is recalling Enzyme Solutions Formula 29 8 oz., lot 1225822 because of a labeling error at the manufacturing. This resulted in 10 jars incorrectly containing a Multiple Enzyme Powder.

Class IIModerate

FDAMay 15, 2013AL, AR, CA +25 more• Enzyme Formulations, Inc.

Proplete 60-69 KG (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Fresenius Bag 1% Amino Acids (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Proplete 90+ KG (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Gromex Anelina (Gromex) – undeclared bi-sulfites (2013)

Undeclared Allergen

Whole dried shrimp may contain undeclared bi-sulfites. Anelina contains undeclared and unapproved colors..

Class IIModerate

FDAMay 10, 2013CT, NJ, NY +1 more• Gromex Inc.

Sara Lee White Buns (BIMBO) – metal fragment risk (2013)

Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery

Class IIModerate

FDAMay 10, 2013NC, SC, TN +1 more• BIMBO Bakeries USA

Whole Wheat Hamburger Buns (BIMBO) – metal fragment risk (2013)

Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery

Class IIModerate

FDAMay 10, 2013NC, SC, TN +1 more• BIMBO Bakeries USA

Seeded Enriched Buns (BIMBO Bakeries) – Metal Fragment Risk (2013)

Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery

Class IIModerate

FDAMay 10, 2013NC, SC, TN +1 more• BIMBO Bakeries USA

Hamburger Buns (BIMBO) – metal fragment risk (2013)

Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery

Class IIModerate

FDAMay 10, 2013NC, SC, TN +1 more• BIMBO Bakeries USA

Colonial Party Pack Buns (BIMBO) – metal fragment risk (2013)

Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery

Class IIModerate

FDAMay 10, 2013NC, SC, TN +1 more• BIMBO Bakeries USA

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