Archive for the ‘Recalls’ Category
Friday, May 4th, 2012
The U.S. Pharmacopeial Convention (USP) has pulled together a broad swath of stakeholders for a workshop this month on the complexities of protecting the supply chain.
The May 22-23 event in Rockville, MD will feature regulatory officials from Europe, South American, and Africa, and coverage of developing track-and-trace standards, among other ...
Posted in Bar Coding, Counterfeiting, Diversion, Electronic Pedigrees, FDA, Fraud, Medical Devices, Recalls, Reimportation, Safety, security, serialization, standards, supply chain, Tampering, Theft | No Comments »
Wednesday, February 1st, 2012
Pfizer took to the Internet today to address its voluntary recall of approximately one million packs of birth control pills. Recalled are 28 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) and Norgestrel and Ethinyl Estradiol Tablets (generic) birth control pills in the United States.
Pfizer's Chief Medical Officer Freda Lewis-Hall explained ...
Posted in Blisters, FDA, Inspection, Recalls, Safety | No Comments »
Monday, January 30th, 2012
Earlier this month Bedford Laboratories updated guidance on its August 2011 recall of Polymyxin B for Injection USP and Vecuronium Bromide for Injection. Since there have been a number of recalls throughout the industry involving glass vials, we posed a few questions regarding the updated guidance. (Note: Bedford Laboratories ...
Posted in Recalls | 1 Comment »
Wednesday, November 30th, 2011
As the end of 2011 nears, we'll all be looking back to ensure we've wrapped up any unfinished business and making resolutions for 2012.
Is preventive maintenance on your list?
Or has your schedule slipped? If so, how do you know whether your machinery is still operating to your specifications? Could product ...
Posted in FDA, machinery, Recalls, Safety | No Comments »
Thursday, September 29th, 2011
The Institute for Safe Medication Practices (ISMP) has surveyed pharmacists and purchasing agents on drug shortages and the "gray" market again, and the bad news is that we could have just reposted our blog on last year's survey and been just as timely. Hospitals continue to struggle with drug shortages, ...
Posted in Compliance Packaging, Counterfeiting, Diversion, Electronic Pedigrees, FDA, Handling, Hospital, Inspection, Medical Devices, Quality, Recalls | No Comments »
Wednesday, September 14th, 2011
GS1 Healthcare standards are gaining traction. As the latest country to support GS1, India has called for serialized codes following GS1 data formats for exported pharmaceuticals. Most of the top pharmaceutical and medical device companies, wholesalers, and many hospital systems in the US have embraced GS1 Healthcare’s system for product ...
Posted in Bar Coding, Counterfeiting, Diversion, Electronic Pedigrees, FDA, Labeling, Medical Devices, Medical Errors, Printing and Coding, Recalls, Safety, security, serialization, standards, Theft | No Comments »
Friday, May 20th, 2011
The recalls of last year related to glass particulates in parenteral primary packaging has focused attention on glass delamination. As Rx-360 has reported, the phenomenon, while well described in the literature, is not well understood.
In a May 5 webinar (see archives) sponsored by the American Association of Pharmaceutical Scientists--Glass ...
Posted in Bottles, Inspection, Medical Devices, Medical Errors, Quality, Recalls, Safety, Testing | No Comments »
Friday, April 22nd, 2011
As combination products and co-packaged medical products evolve, there is a shift toward high-quality products that ensure safety and ease-of-use for consumers and healthcare professionals alike. Parenteral product companies are developing pre-filled syringes with superior safety features; pharmaceutical companies in the inhaled space are designing devices and patient-friendly packaging that ...
Posted in Medical Devices, Medical Errors, Quality, Recalls, Safety, Uncategorized | No Comments »
Tuesday, March 22nd, 2011
If the medical device packaging industry were to ever name its most inspiring motivational speakers, Jack Dhuwalia would undoubtedly be on the list. Dhuwalia’s unbridled enthusiasm for the discipline can quickly bolster the confidence of any packaging engineer frustrated by being left out of product development—again.
Dhuwalia spoke about integrating packaging ...
Posted in Medical Devices, Recalls | No Comments »
Friday, February 18th, 2011
Just how easy is it for patients to immediately identify a recalled drug or medical device? Not as easy as I thought, even though it could be as plain as day. Should you make it easier for them?
In January, Triad Group recalled all lots of alcohol prep pads, swabs, and ...
Posted in Printing and Coding, Recalls | No Comments »
