Unapproved Drugs

08
Oct

FDA Warns of Triple-Threat Product Marketed as Dietary Supplement

Well, there is bad, then there is worse!  In this case, the FDA warns us about a product that is being marketed as all natural and promoted as a dietary supplement for joint and muscle pain.  The product, called Trinity Gold, actually contains three undeclared drug ingredients, acetaminophen, diclofenac, and phenylbutazone (which was removed from […]

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10
Sep
U.S. and EU Drug Shortages - Lachman Consultants

New Risks Discovered as U.S. and EU Drug Shortage Efforts Start to Merge

U.S. and EU efforts to manage supply chain shortages are slowly converging; however, the political winds in the Rest of World (ROW) may be diluting required oversight.  Both the U.S. (Risk Management Plans to Mitigate the Potential for Drug Shortages | FDA) and EU (Shortage Prevention Plan (SPP) – template (europa.eu)) have published either a […]

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11
Jun
Interesting Facts from Fiscal Year 2023 Report on the State of Pharmaceutical Quality - Lachman Blog

Interesting Facts from Fiscal Year 2023 Report on the State of Pharmaceutical Quality

Each year, the Office of Pharmaceutical Quality (OPQ) releases a report on the state of pharmaceutical quality. This year’s report was released yesterday and can be found here. Every year we try to pick out key issues and highlight some of the statistics outlined in the report, and this year is no different! Some important […]

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23
May
Roadside trailer with local produce for sale, Mendoza, Argentina.

Fraudulent Drugs: A Struggle That FDA Grapples with Every Day

We have written a lot about fraudulent drugs over the years.  Some examples of these include counterfeit drugs, dietary ingredients that are unsafe, dietary drugs that contain undeclared prescription drugs in them, and the list goes on and on.  In his presentation titled “Fraudulent Drugs: You’re Taking What?” (here), Brad Pace, Associate Director, Office of […]

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27
Mar

FDA Warns of Danger for Unapproved Topical Products Containing Lidocaine 

In a press release issued yesterday (here), the FDA warned six companies about topical lidocaine products that can cause serious health effects and are also unapproved new drugs.  The products are recommended for use after certain dermatological procedures “such as microdermabrasion, laser hair removal, tattooing and piercing.”  These products are being marketed at concentrations above […]

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01
Mar
medical fraud

FDA Provides Advisory on Two More Dietary Supplements with Hidden Drug Ingredients

Yesterday, the FDA advised consumers not to use QUICK Rheumatism Capsule, Tiger Wang Biaod (here) or SNAKE BONES Anti-Rheumatic Capsules (here).  The FDA confirmed by its laboratory analysis that both products contain piroxicam, a prescription drug ingredient for treating pain and arthritis-related symptoms. Serious adverse events can occur with taking any of these unapproved drugs […]

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06
Feb
Paper clipboard with text POLICIES AND PROCEDURES.

CARES ACT – 2024 Update – Big News!

Since the implementation of the CARES Act reporting requirement, the question continues to be asked: Is it really a requirement?  The answer is yes, and now it is no longer recommended, but is stated as “should” in the newly published Final version of the Guidance for Industry (GFI) “Reporting Amount of Listed Drugs and Biological […]

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31
Jan

FDA Warns About Yet Another “Fake” Set of Eye Drop Products

Today, the FDA is warning consumers of potentially contaminated copycat eye drops that are unapproved new drugs that “copy the Bausch + Lomb’s Lumify brand eye drops, an over-the-counter product approved for redness relief.” While the FDA notes that it has not received any specific reports of adverse events with the three products named below, […]

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17
Jan
Office of Compliance Issues FY 2023 Annual Report - Lachman Blog2

FDA’s Office of Compliance Issues FY 2023 Annual Report

Some of the big-ticket items mentioned in the FY 2023 report are Office of Compliance (OC) actions taken regarding the “contamination from diethylene glycol and ethylene glycol (DEG/EG), potentially harmful eye products, and mitigating risks from drug shortages while ensuring the safety our drug supply.” These issues caused the OC to “pivot” from its business as […]

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22
Nov

A New Wave of Warnings for Pain Relief Products with Hidden Drug Ingredients 

Just like the FDA says on its warnings and notifications page (here):  “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers. FDA cannot test all products on the market that contain […]

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