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Showing 12101–12120 of 14370 results

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Interfase Plus (ProThera) – Enzyme Contamination (2013)

ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol.

Class IIModerate

FDAOct 10, 2013Nationwide• ProThera, Inc.

Bella Vi BTrim ULTIMATE BOOST (Pure Edge Nutrition) – undeclared ingredients (2013)

Undeclared Allergen

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

FDAOct 10, 2013Nationwide

• Pure Edge Nutrition

Oxygen Compressed (Airgas Medical) – potential empty cylinder (2013)

Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.

Class IIModerate

FDAOct 10, 2013IN, MA, NH +2 more• Airgas Medical Services

Bella Vi INSANE AMP'D (Pure Edge Nutrition) – undeclared ingredients (2013)

Undeclared Allergen

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

FDAOct 10, 2013Nationwide• Pure Edge Nutrition

Klaire Labs Interfase (ProThera) – Enzyme Contamination (2013)

ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol.

Class IIModerate

FDAOct 10, 2013Nationwide• ProThera, Inc.

Total Probiotics (Nutri-West) – Potential Contamination (2013)

Nutrition Center voluntarily recalled Total Enzymes and Total Probiotics after notification from supplier that raw materials may potentially contain Chloramphenicol.

Class IIModerate

FDAOct 10, 2013Nationwide• Nutrition Center, Inc. dba Nutri-West

Bella Vi INSANE Bee Pollen (Pure Edge Nutrition) – undeclared ingredients (2013)

Undeclared Allergen

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

FDAOct 10, 2013Nationwide• Pure Edge Nutrition

Total Enzyme (Nutri-West) – Potential Contamination (2013)

Nutrition Center voluntarily recalled Total Enzymes and Total Probiotics after notification from supplier that raw materials may potentially contain Chloramphenicol.

Class IIModerate

FDAOct 10, 2013Nationwide• Nutrition Center, Inc. dba Nutri-West

Bella Vi eXtreme ACCELERATOR (Pure Edge Nutrition) – undeclared ingredients (2013)

Undeclared Allergen

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

FDAOct 10, 2013Nationwide• Pure Edge Nutrition

Bella Vi AMP'D UP (Pure Edge Nutrition) – undeclared ingredients (2013)

Undeclared Allergen

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

FDAOct 10, 2013Nationwide• Pure Edge Nutrition

Bella Vi BTrim MAX (Pure Edge Nutrition) – undeclared ingredients (2013)

Undeclared Allergen

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

FDAOct 10, 2013Nationwide• Pure Edge Nutrition

Alprazolam Tablets (Actavis) – Tablet Weight Deviation (2013)

Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets

Class IIModerate

FDAOct 9, 2013Nationwide• Actavis Elizabeth LLC

Ropinirole Tablets (Sandoz) – cross-contamination risk (2013)

Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.

Class IIModerate

FDAOct 9, 2013Nationwide• Sandoz, Inc

Metformin Hydrochloride (Betachem) – CGMP Deviation (2013)

CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.

Class IIModerate

FDAOct 7, 2013MO• Betachem, Inc.

Optimize Enzymes Capsules (Cgnp) – Ingredient Concern (2013)

CGNP initiated this recall because the raw material Exclezyme received from Specialty Enzymes used by CGNP in the formulation of Beachbody Optimize Enzymes Capsules CG has been found to contain chloramphenicol.

Class IIModerate

FDAOct 7, 2013CA• Cgnp Manufacturing

Beach Body Reset Kit (Cgnp) – Enzyme Ingredient Issue (2013)

CGNP initiated this recall because the raw material Exclezyme received from Specialty Enzymes used by CGNP in the formulation of Beachbody Optimize Enzymes Capsules CG has been found to contain chloramphenicol.

Class IIModerate

FDAOct 7, 2013CA• Cgnp Manufacturing

Dexedrine Spansules (Amedra) – Dissolution Specification Failure (2013)

Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.

Class IIModerate

FDAOct 7, 2013Nationwide• Amedra Pharmaceuticals LLC

Slim Expert Softgels (B @ B Trade) – Undeclared Sibutramine (2013)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine

FDAOct 7, 2013Nationwide• B @ B Trade Inc.

Lidiy Capsules (B @ B Trade) – Undeclared Sibutramine (2013)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine

FDAOct 7, 2013Nationwide• B @ B Trade Inc.

Slim Fortune Capsules (B @ B Trade) – Undeclared Sibutramine (2013)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine

FDAOct 7, 2013Nationwide• B @ B Trade Inc.

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