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Home > FDA, regulatory and legal 

FDA, regulatory and legal

Columns examine the legal and regulatory developments, guidances, and rulings that affect the packaging of drugs, biologics, and medical devices.

Pfizer recalls 1M birth control packs after mix-up

Birth control pills are known to be nearly 100 percent effective when taken properly, but a recall of the drugs could send a shudder through women of childbearing age. A manufacturing mix-up by Pfizer Inc., the world's largest drug maker,...

Vitaflo USA Renastart: Recall - Possible Health Risk Due To Incorrectly Labeled Cans

AUDIENCE: Pediatrics, Health Professionals, Consumers ISSUE: Vitaflo USA has announced a voluntary recall of Renastart 14.11 oz (400g) cans, Batch Number 12832, because some of the product shipped throughout the United States during the period December 29, 2011 through January...

Treanda (bendamustine HCL): Recall - Particulate Matter in Vial

AUDIENCE: Risk Manager, Oncology, Pharmacy ISSUE: Cephalon, Inc. notified healthcare professionals of a recall of Treanda (bendamustine HCL) for Injection 25mg/8mL, lot TB30111, expiration date 12/2012. This product lot is being recalled due to the presence of particulate matter found...

Packaging issue leads to voluntary Pfizer recall

Twenty-eight lots, or approximately one million packs of contraceptive products, are recalled due to out-of-order placebo pill placement in some packs....

New folding machine produces for Gooding

Machinery investment allows insert/outsert manufacturer to produce up to 210 panels, helping pharmaceutical customers comply with FDA rule changes....

FDA regulatory changes lead to folder installation

Pharmaceutical paperboard packaging company installs second folder to produce patient-information leaflets for the healthcare market....

Vagifresh Ball, Vagifresh Gel, Female One: Recall - Undeclared Drug Ingredient, Bacterial Contamination

AUDIENCE: Consumer, OB/GYN ISSUE: USA Far Ocean Group Inc. notified the public of a recall of Vagifresh Ball and Vagifresh Gel, sold as cosmetics. Vagifresh Gel was found by FDA analysis to contain benzocaine, an active ingredient for many anesthetic...

FDA Grants 510(k) Clearance to Curos® Disinfecting Port Protector

Ivera Medical Corporationtoday announced it has received a new FDA 510(k) clearance for its Curos® disinfecting port protector which reflects the company's ongoing determination to continuously improve its products to better deliver solutions designed to reduce hospital-acquired catheter related bloodstream...

Packaging and cough-and-cold meds for children

With cold and flu season here again, it's time to pay attention to packaging to protect children....

December 2011 Safety Labeling Changes posting includes 40 products

The MedWatch December 2011 Safety Labeling Changes posting includes 40 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The "Summary Page" provides a listing of drug names and...

FDA Clears PICO* Single Use Negative Pressure Wound Therapy System From Smith & Nephew, Expanding Patient Access

Smith & Nephew plc (LSE: SN, NYSE: SNN), the global medical technology business, announces the FDA clearance of the pocket-sized PICO* system, a single use Negative Pressure Wound Therapy (NPWT) system. PICO is cleared for use both in a hospital...

Pharmaceutical packaging makes news

While more details emerge in the Novartis recall, a ’60 Minutes’ segment, and a ban on inhalers shine the media spotlight on pharmaceutical and biologics packaging....

Broken products prompt voluntary Novartis recall

Novartis Consumer Health Inc. issues nationwide recall of certain OTC products due to potential presence of foreign tablets or chipped or broken tablets or gelcaps....

Sunkist's pouch tops Healthcare Packaging's top 10 in 2011

Package innovation, trends, regulations, and track-and-trace issues pique reader interest....

FDA targets risks from reused medical devices, redesigns Web site

Agency is working with healthcare providers, manufacturers, and other agencies to reduce risk from infection due to inadequate device reprocessing....

Methotrexate Safety information

Addition of new safety information to methotrexate package inserts This is to inform you of changes that have been made to the package inserts for methotrexate products for intravenous administration. The following has been added to the WARNINGS section of...

Packaging helps prevent children from overdosing from medicines at home

New educational program reminds parents to keep packaged medications 'Up and Away and Out of Sight.'...

'Largest generic drug launch in history' begins

Pfizer offers discounts to protect its top-selling cholesterol drug as the first generic version of Lipitor is approved by the FDA....

October 2011 Drug Safety Labeling Changes: 48 products with 28 changes to BW, Contraindications or Warnings

Device ID plan brewing: Drip, drip, drip

FDA sends labeling to the rescue in aiding with medical device track and trace, safety, and counterfeiting prevention....

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