Unapproved Drugs

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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23
Aug
Here’s a Surprise! FDA Warns About Undeclared Active Ingredients in Sexual Enhancement Products!

Here’s a Surprise! FDA Warns About Undeclared Active Ingredients in Sexual Enhancement Products!

Today FDA has warned consumers (here) that the products listed below that are offered for sale in the US contain undeclared active ingredients that can be dangerous for some users. This is not really a surprise as unscrupulous manufacturers and distributors try to cash in on patients with erectile disfunction or on users that merely […]

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15
Aug

Something’s Not Right Here – How Does This Happen?

On August 8, 2023, Axios reported (here) that the Pentagon began contracting with Valisure, a drug testing facility, to test the generic drugs that it is purchasing.  On August 9, 2023, Bloomberg reported much the same thing in an article titled “Tainted Medicine Fears Spur Pentagon to Seek Outside Testing” (here; subscription required).  Congress has been pushing […]

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11
May

In the First 11 days of May FDA Warns Against Use of 21 Products

While we know there are probably thousands of unapproved drug products being marketed in the US, many of which claim to be dietary supplements which have undeclared drugs in their composition, the danger of these products cannot be understated.  Just search the web for erectile disfunction products, weigh loss products, products claiming to prevent, cure […]

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10
Jun

Moles Can Be Dangerous (and Not Just in Your Yard) – FDA Warns Consumers that Danger Lurks in Unapproved Products

The FDA issued a warning to consumers (here) that mole removal isn’t a DIY project and can be dangerous for a number of reasons.  It warns that there is no FDA-approved OTC product for removing moles or skin tags.  Unauthorized products, like those with a high‑level of salicylic acid, claiming to remove these lesions can […]

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