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Showing 11681–11700 of 14370 results

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Activity Girl Capsules (MyNicNaxs) – Undeclared Ingredient (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine

FDAJan 24, 2014Nationwide• MyNicNaxs, Inc.

Reduce Weight Fruta Planta (MyNicNaxs) – Undeclared Ingredient (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.

Jan 24, 2014

Nationwide

• MyNicNaxs, Inc.

Magic Slim Capsules (MyNicNaxs) – Undeclared Ingredients (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine

FDAJan 24, 2014Nationwide• MyNicNaxs, Inc.

Hydroxyzine Pamoate Capsules (Teva) – CGMP Manufacturing Deviation (2014)

CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.

Class IIModerate

FDAJan 24, 2014Nationwide• Teva Pharmaceuticals USA

Ethambutol Tablets (Teva) – CGMP Manufacturing Deviation (2014)

CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.

Class IIModerate

FDAJan 24, 2014Nationwide• Teva Pharmaceuticals USA

Meizitang Botanical Slimming (MyNicNaxs) – Undeclared Ingredients (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine

FDAJan 24, 2014Nationwide• MyNicNaxs, Inc.

Fruta BIO Capsules (MyNicNaxs) – Undeclared Ingredients (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .

FDAJan 24, 2014Nationwide• MyNicNaxs, Inc.

Fat Burning Bomb Capsules (MyNicNaxs) – Undeclared Ingredients (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine

FDAJan 24, 2014Nationwide• MyNicNaxs, Inc.

Meizi Evolution Capsules (MyNicNaxs) – Undeclared Ingredients (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine

FDAJan 24, 2014Nationwide• MyNicNaxs, Inc.

SlimEasy Herbs Capsules (MyNicNaxs) – Undeclared Ingredients (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine

FDAJan 24, 2014Nationwide• MyNicNaxs, Inc.

Heparin Sodium Injection (Fresenius) – Subpotent Medication (2014)

Subpotent; 18 month time point

Class IIModerate

FDAJan 22, 2014Nationwide• Fresenius Kabi USA, LLC

San Francisco Sourdough (Farm to Market) – Undeclared Wheat (2014)

Undeclared Allergen

The product label does not list wheat flour as an ingredient. Undeclared allergen.

Class IIModerate

FDAJan 18, 2014IN, KS, MO• Farm To Market Bread Co Inc

StemAlive Capsules (Stemvida) – Undeclared Milk (2014)

Undeclared Milk

Stemvida International Corporation of Ontario California is recalling certain lots of StemAlive 90 Capsules, because it contains undeclared milk.

FDAJan 17, 2014AZ, CA, CO +7 more• STEMVIDA INTERNATIONAL INC

ROHTO Redness Relief (Mentholatum) – sterility concern (2014)

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Class IIModerate

FDAJan 16, 2014Nationwide• The Mentholatum Co.

ROHTO Cooling Eye Drops (Mentholatum) – sterility concern (2014)

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Class IIModerate

FDAJan 16, 2014Nationwide• The Mentholatum Co.

Atorvastatin Calcium Tablets (Ranbaxy) – foreign tablet mix (2014)

Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.

Class IIModerate

FDAJan 16, 2014Nationwide• Ranbaxy Inc.

Hydrocodone Acetaminophen Tablets (Watson) – broken tablets (2014)

Failed Tablet/Capsule Specifications; Product contains broken tablets.

Class IIModerate

FDAJan 15, 2014AZ, CA, CT +8 more• Watson Laboratories Inc

Levothyroxine Sodium Tablets (Mylan) – subpotent medication (2014)

Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.

Class IIModerate

FDAJan 14, 2014Nationwide• Mylan Pharmaceuticals Inc.

Liptruzet 10/80 (Merck) – packaging defect (2014)

Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

FDAJan 13, 2014Nationwide• Merck & Co Inc

Liptruzet 10/40 (Merck) – packaging defect (2014)

This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

FDAJan 13, 2014Nationwide• Merck & Co Inc

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