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Industry News: Page 266
Supply Chain
Temperature-monitoring labels
• PakSense BIOmed Label enables cold chain monitoring in virtually any packaging configuration, including on the pallet, carton, or individual item
January 11, 2011
Nutraceuticals/Dietary
A drug by any other name might still be a drug
Labeling claims, but also ingredients, key when dietary supplements are judged.
January 10, 2011
Regulatory
FDA MedWatch - Acetadote (acetylcysteine) Injection: Recall - Particulate Matter Found in a Small Number of Vials
AUDIENCE: Hospital Risk Managers, Pharmacy, Emergency Medicine
January 5, 2011
Pharmaceuticals
Is packaging part of the problem or solution in the pharmaceutical sector?
Drug shortages, recalls, and layoffs stress the pharmaceutical industry. Do manufacturing/production problems include packaging? What's your take?
January 3, 2011
Regulatory
November 2010 Safety Labeling Changes: 37 Medical Product Labels with changes to Warnings, Contraindications, Precautions, Adverse Reactions
The MedWatch November 2010 Safety Labeling Changes posting includes 37 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
December 30, 2010
Regulatory
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vial: Recall due to Particulates in Product
American Regent and FDA notify healthcare professionals of recall of specific lots of Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL, 30mL Multiple Dose Vial.
December 28, 2010
Regulatory
Man Up Now Capsules: Consumer Warning - Undeclared Drug Ingredient
FDA warned consumers not to use Man Up Now capsules, marketed as a dietary supplement for sexual enhancement, because FDA analysis determined that the product contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, this chemical may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure.
December 15, 2010
Nutraceuticals/Dietary
Reese Pharmaceutical Company OTC Products: Recall - Mislabeled Guaifenesin Tablets
Refenesen Expectorant (guaifenesin 200 mg tablets) Select Brand Mucus Relief Expectorant (guaifenesin 200 mg) QC Medifin Expectorant (guaifenesin 200 mg) Leader Cough Tabs Expectorant (guaifenesin 200 mg)
December 15, 2010
Traceability/Serialization
Marking and verification system
December 6, 2010
Regulatory
Kenya employs cutting-edge mobile phone anti-counterfeiting technology
With growing bandwidth availability and the increasing popularity of mobile phones among consumers, the Kenyan government endorses the mPedigree platform to battle pharmaceutical counterfeiting.
December 6, 2010
Regulatory
B. Braun addEASE Binary Connector: Class I Recall -Stopper Fragments May Enter Bag
When the addEASE binary connector is inserted into a partial additive bag (PAB) stopper, fragments of the stopper may enter the bag, resulting in a small amount of visible particles in the solution.
December 1, 2010
Regulatory
October 2010 Safety Labeling Changes: 34 Medical Product Labels with changes to Boxed Warnings, Contraindications, Precautions, Adverse Reactions
The MedWatch October 2010 Safety Labeling Changes posting includes 34 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
November 29, 2010
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