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1,251 Results
Type: News
Section: Industry News > Regulatory
Pharmaceuticals
Alka-Seltzer Recalled Due to Label Mix-Up
Bayer is recalling Alka-Seltzer Plus products because the ingredients on the front sticker don’t match the product in the carton.
March 19, 2018
Alka-Seltzer Plus Recall Graphic / Image: ABC News
Cannabis
Colorado's New 'Universal' Marijuana Packaging Symbol
The symbol has two different versions, including one for edibles, and it applies to both medical and recreational products.
March 15, 2018
The red symbol for all types of retail and medical marijuana, must include the warning 'Contains Marijuana. Keep away from Children.' The symbol must be at least 1⁄2 in. by 1⁄2 in. on the packaging/labeling.
Regulatory
Kratom Powder Probably Shouldn’t Contain Salmonella
A Portland-based aromatics company has recalled kratom-containing powder products due to Salmonella contamination.
March 15, 2018
Some of the product affected by the recall.
Pharmaceuticals
Nanoparticle Eye Drops Improve Vision
Israeli ophthalmologists have invented and tested “nanodrops” that, when paired with a laser process, improve near- and far-sightedness.
March 14, 2018
Nanoparticle Eye Drops Improve Vision / Image: Eric Audras
Pharmaceuticals
RFID, Carton Serialization Boost Track-and-Trace Market
New report predicts an 18.9% CAGR for track-and-trace solutions through 2023, but high costs and a lack of standards will likely hinder growth.
March 12, 2018
New report predicts an 18.9% CAGR for track-and-trace solutions through 2023, but high costs and a lack of standards will likely hinder growth.
Medical Device/Packaging
FDA Warns Duodenoscope Manufacturers for Compliance Failures
Agency issues warning letters to Olympus, Fujifilm and Pentax for failure to comply with required postmarket surveillance studies to assess contamination risk.
March 9, 2018
Agency issues warning letters to Olympus, Fujifilm and Pentax for failure to comply with required postmarket surveillance studies to assess contamination risk.
Regulatory
New Draft Guidance Issued for Animal Drug Names
FDA's goal is to help sponsors avoid contributing to medication errors, encouraging public comment by May 11, 2018.
March 9, 2018
FDA's goal is to help sponsors avoid contributing to medication errors, encouraging public comment by May 11, 2018.
Pharmaceuticals
FDA Calls for Boycott of Cantrell Drugs
The FDA has alerted health care professionals and patients not to use Cantrell’s compounded drugs due to quality and sterility issues.
March 9, 2018
Cantrell Drus Recalled / Image: RTTNews
Pharmaceuticals
Cracked Glass Vials Lead to Recall for Hospira Opioid
Hospira is voluntarily recalling Hydromorphone HCl Injections due to the potential for empty or cracked glass vials.
March 8, 2018
Hydromorphone Injection
Adherence/Delivery
Now Trending: Personalized Medicines, Intelligent Packaging and FDA Deadlines
Experts debate key trends and developments now unfolding in the pharmaceutical packaging community.
March 8, 2018
Advancing technologies are driving pharmaceutical packaging, as evidenced at Pharmapack Europe 2018.
Pharmaceuticals
Pharma Distributors Fund Alliance Against Opioid Abuse (AAOA)
In response to Attorney General Jeff Sessions’ new opioid task force targeting drug manufacturers and distributors, the pharmaceutical industry has launched a national education and awareness initiative.
March 7, 2018
In response to Attorney General Jeff Sessions’ new opioid task force targeting drug manufacturers and distributors, the pharmaceutical industry has launched a national education and awareness initiative.
Pharmaceuticals
Peanut Allergy Drug Nears FDA Approval
Aimmune Therapeutics’ treatment consists of repeated exposure to small doses of peanut flour to build up immunity.
March 6, 2018
Peanut Allergy Pill Nears FDA Approval / Image: Marcduf/iStock
Medical Device/Packaging
ASTM International Packaging Standard to Aid Medical Devices Industry
To help validate test methods for packaging on medical devices, this new guide aims to help support product quality and safety.
March 5, 2018
To help validate test methods for packaging on medical devices, this new guide aims to help support product quality and safety.
Traceability/Serialization
FDA: Two New Track and Trace Guidance Docs
The documents are part of FDA’s effort to standardize terms to ensure data is captured and shared in a way that facilitates communication between supply chain partners.
March 5, 2018
The documents are part of FDA’s effort to standardize terms to ensure data is captured and shared in a way that facilitates communication between supply chain partners.
Medical Device/Packaging
Medtronic Recalls Implantable Defibrillators
The FDA has issued a Class I recall of a Medtronic defibrillator with a potentially lethal malfunction due to a manufacturing defect.
February 28, 2018
Medtronic Evera / Image: Medtronic
Pharmaceuticals
HDA Calls for Universal Suspicious Orders Database
Healthcare Distribution Alliance asks Drug Enforcement Administration to allow state regulators and DEA’s state and local law enforcement partners to access DEA’s database.
February 23, 2018
Pharmaceuticals
Amazon Pilots Anti-Counterfeiting Service
The online retail giant has invited 1,000 brands to test a new anti-counterfeiting service called Transparency.
February 20, 2018
Amazon Transparency / Image: Amazon
Pharmaceuticals
Packaging Mix-Up May Cause Excessive Urination
Apace Packaging is recalling 4000mg Acyclovir tablets that due to a packaging error may also include Torsemide.
February 19, 2018
Acyclovir Tablets
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