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Showing 11661–11680 of 14370 results

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Derma-Smoothe Scalp Oil (Hill Dermaceuticals) – Low Potency (2014)

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

FDAJan 31, 2014Nationwide• Hill Dermaceuticals, Inc.

Derma-Smoothe Scalp Oil (Hill Dermaceuticals) – Low Potency (2014)

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

FDAJan 31, 2014Nationwide• Hill Dermaceuticals, Inc.

HydrOXYzine Tablets (American Health) – Unapproved Ingredient (2014)

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Class IIModerate

FDAJan 31, 2014Nationwide• American Health Packaging

DermOtic Oil (Hill Dermaceuticals) – Low Potency (2014)

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

FDAJan 31, 2014Nationwide• Hill Dermaceuticals, Inc.

HydrOXYzine Tablets (American Health) – Unapproved Ingredient (2014)

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Class IIModerate

FDAJan 31, 2014Nationwide• American Health Packaging

Derma-Smoothe Body Oil (Hill Dermaceuticals) – Low Potency (2014)

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

FDAJan 31, 2014Nationwide• Hill Dermaceuticals, Inc.

DermOtic Ear Drops (Hill Dermaceuticals) – Low Potency (2014)

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

FDAJan 31, 2014Nationwide• Hill Dermaceuticals, Inc.

Mega Slim Herbal Capsules (YoungYou) – Voluntary Product Recall (2014)

YoungYou International is voluntarily recalling Mega Slim Herbal Appetite Management, 30 capsules, sold from September 15, 2013 through January 23, 2014, because it was found to contain DMAA.

Class IIModerate

FDAJan 30, 2014Nationwide• YoungYou International Inc

Triamcinolone Cream (Fougera) – Labeling Error (2014)

Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.

FDAJan 29, 2014Nationwide• Fougera Pharmaceuticals Inc.

Oxcarbazepine Tablets (Caraco) – Broken Tablets (2014)

Failed Tablet Specifications: Broken Tablets Present.

Class IIModerate

FDAJan 29, 2014Nationwide• Caraco Pharmaceutical Laboratories Ltd.

Fluconazole Suspension (Pfizer) – Container Defect (2014)

Defective Container: Tamper evident ring failures discovered on some bottles.

Class IIModerate

FDAJan 29, 2014Nationwide• Pfizer Inc.

Metformin HCl Extended-Release (Caraco) – Foreign Tablet Contamination (2014)

Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER

Class IIModerate

FDAJan 28, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Hydroxyprogesterone Caproate (RX3 Pharmacy) – Crystallization Risk (2014)

Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping

Class IIModerate

FDAJan 28, 2014IN, MD, VA• RX South LLC DBA RX3 Pharmacy

Carisoprodol Tablets (Mylan) – Impurity Specification Failure (2014)

Failed Impurity/degradation Specification

FDAJan 28, 2014Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Suprax Cefixime Suspension (Lupin) – Impurity Specification Failure (2014)

Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.

FDAJan 27, 2014Nationwide• Lupin Pharmaceuticals Inc.

Suprax Cefixime Suspension (Lupin) – Impurity Specification Failure (2014)

Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.

FDAJan 27, 2014Nationwide• Lupin Pharmaceuticals Inc.

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

CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.

Class IIModerate

FDAJan 24, 2014Nationwide• Teva Pharmaceuticals USA

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.

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.

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