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Yesterday β€” 19 September 2024Main stream

Homeopathic company refuses to recall life-threatening nasal spray, FDA says

By: Beth Mole
19 September 2024 at 20:40
Homeopathic company refuses to recall life-threatening nasal spray, FDA says

Enlarge (credit: Getty | Florian Gaertner)

The maker of a homeopathic nasal spray with a history of contamination is refusing to recall its product after the Food and Drug Administration once again found evidence of dangerous microbial contamination.

In a warning Thursday, the FDA advised consumers to immediately stop using SnoreStop nasal sprayβ€”made by Green Pharmaceuticalsβ€”because it may contain microbes that, when sprayed directly into nasal cavities, can cause life-threatening infections. The FDA highlighted the risk to people with compromised immune systems and also children, since SnoreStop is marketed to kids as young as age 5.

According to the regulator, an FDA inspection in April uncovered laboratory test results showing that a batch of SnoreStop contained "significant microbial contamination." But, instead of discarding the batch, FDA inspectors found evidence that Green Pharmaceuticals had repackaged some of the contaminated lot and distributed it as single spray bottles or as part of a starter kit.

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Before yesterdayMain stream

ADHD med shortages push DEA to up drug allotment by 23.5%

By: Beth Mole
6 September 2024 at 21:22
ADHD med shortages push DEA to up drug allotment by 23.5%

Enlarge (credit: Getty | George Frey)

While supplies of Adderall and its generic versions are finally recovering after a yearslong shortage, the Drug Enforcement Administration is now working to curb the short supply of another drug for attention-deficit/hyperactivity disorder: Vyvanse (lisdexamfetamine) and its generic versions.

This week, the DEA said it will increase the allowed production amount of lisdexamfetamine by roughly 23.5 percent, increasing the current 26,500 kg quota by 6,236 kg, for a new total of 32,736 kg. The DEA also allowed for a corresponding increase in d-amphetamine, which is needed for production of lisdexamfetamine.

"These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally," the DEA said.

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