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Showing 10321–10340 of 14370 results

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AMPD GOLD Bee Pollen Capsules (Detox Transforms) – Undeclared Sildenafil (2015)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug.

FDAJan 25, 2015Nationwide• Detox Transforms

EDGE Weight Release Capsules (Detox Transforms) – Undeclared Ingredients (2015)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug.

Jan 25, 2015

Nationwide

• Detox Transforms

BtRiM Max Capsules (Detox Transforms) – Undeclared Chemical (2015)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug.

FDAJan 25, 2015Nationwide• Detox Transforms

Nicardipine Hydrochloride Injection (Mylan) – Potency Issue (2015)

Subpotent Drug and Failed Impurities/Degradation Specifications

FDAJan 23, 2015Nationwide• Mylan Institutional LLC

Ketorolac Ophthalmic Solution (Sun Pharma) – Particulate Contamination (2015)

Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.

Class IIModerate

FDAJan 21, 2015Nationwide• Sun Pharma Global Fze

Levetiracetam Extended Release Tablets (Sun Pharma) – Dissolution Failure (2015)

Failed Dissolution Specifications: 6 month time point.

Class IIModerate

FDAJan 21, 2015Nationwide• Sun Pharma Global Fze

Sodium Chloride Injection (Hospira) – Particulate Contamination (2015)

Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.

FDAJan 20, 2015Nationwide• Hospira Inc.

Daytrana Patch (Noven) – Delivery System Defect (2015)

Defective Delivery System: One lot exceeded the mechanical peel specification

Class IIModerate

FDAJan 12, 2015Nationwide• Noven Pharmaceuticals, Inc.

Melatonin Control- Released Tablets, 60 tablets, in plast... (HVL, LLC) – bottles contained a vegetarian digest... (2015)

Bottles contained a vegetarian digestive enzyme dietary supplement instead of melatonin.

FDAJan 12, 2015Nationwide• HVL, LLC

5-methyltetrahydrofolate Calcium (Freedom Pharmaceuticals) – Subpotent Drug (2015)

Subpotent Drug

FDAJan 8, 2015Nationwide• Freedom Pharmaceuticals Inc

Benzonatate Capsules (American Health) – Wet Capsules (2015)

Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules

Class IIModerate

FDAJan 6, 2015Nationwide• American Health Packaging

Glycopyrrolate Injection (SCA Pharmaceuticals) – Labeling Error (2015)

Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".

Class IIModerate

FDAJan 2, 2015LA• SCA Pharmaceuticals

Thera Tablets (Harvard Drug) – labeling issue (2014)

The firm received a complaint that the blister packets were missing labeling information on 12/16/2014, the firm investigated the labeling complaint and found that six 2 x 5 blister cards inside a carton was missing some or all of the product information on the back of the blister card.

FDADec 31, 2014AL, AZ, CA +24 more• The Harvard Drug Group, LLC

Virazole (Valeant) – Non-sterile contamination (2014)

Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.

Class IIModerate

FDADec 31, 2014Nationwide• Valeant Pharmaceuticals North America LLC

Children's Loratadine Syrup (Taro) – Blue plastic found (2014)

Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.

Class IIModerate

FDADec 30, 2014Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Immune Globulin G (Walgreens) – Sterility Concerns (2014)

Lack of sterility assurance.

Class IIModerate

FDADec 26, 2014FL, GA, LA +3 more• Walgreens Infusion Services

Aztreonam Saline (Walgreens) – Sterility Concerns (2014)

Lack of sterility assurance.

Class IIModerate

FDADec 26, 2014FL, GA, LA +3 more• Walgreens Infusion Services

Thiamine Vials (Walgreens) – Sterility risk (2014)

Lack of sterility assurance.

Class IIModerate

FDADec 26, 2014FL, GA, LA +3 more• Walgreens Infusion Services

Dehydrated Alcohol Vials (Walgreens) – Sterility Concerns (2014)

Lack of sterility assurance.

Class IIModerate

FDADec 26, 2014FL, GA, LA +3 more• Walgreens Infusion Services

Daptomycin Injection (Walgreens) – Sterility risk (2014)

Lack of sterility assurance.

Class IIModerate

FDADec 26, 2014FL, GA, LA +3 more• Walgreens Infusion Services

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