Last Updated on October 2, 2024 by The Health Master
Drug recall
Drug recall: Biomic Sciences is voluntarily recalling all lots of ION Sinus Support, ION Sinus, and Restore Sinus Spray products to the consumer level.
DA testing found the product to contain microbial contamination identified as Microbacterium sp., Fictibacillus sp., Bacillus sp., (primarily B. malikii), and Paenibacillus sp (these microorganisms are generally non-pathogenic).
Risk Statement:
In the population most at risk, patients or individuals who recently underwent nasal or sinus surgery, there is a reasonable probability that the use of the affected product could potentially result in severe or life-threatening adverse events such as bacteremia or fungemia, invasive bacterial or fungal rhinosinusitis, or disseminated fungal infection.
To date, Biomic Sciences has not received any reports of adverse events related to this product.
The product is used as a nasal rinse and is packaged in individual boxes of one or two nasal spray dispensers. All lots of the of the following products are covered by this recall:
| Product Name | Sales Period |
|---|---|
| ION Sinus Support | September 2021 through September 20, 2023 |
| ION Sinus | September 2019 through September 2021 |
| Restore Sinus Spray | June 2017 through September 2019 |
The affected lots were distributed to wholesale and retail outlets, as well as sold directly to consumers online.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).
Drug recall: 7,248 bottles of Oxybutynin Chloride tablets recalled
Drug recall: These injections recalled due to Glass Particulate Matter
Drug recall: Sun Pharma, Aurobindo recall these drugs due to this reason
Drug recall: Ibrexafungerp tablets recalled due to cross contamination
Drug Recall: Sucralfate Oral Suspension recalled due to this reason
Drug recall: WEFUN Capsules recalled due to presence of undeclared Sildenafil
Fake drug manufacturing factory busted: Dehradun
Reactor blasts in Pharmaceutical Company: Hyderabad
USFDA issues Form 483 with 9 observation to Panacea: Baddi
Govt Job: For the post of Assistant Controller Drugs under Drugs & Food Control
USFDA tentative approval granted for Apalutamide tablets
Drug recall: 7,248 bottles of Oxybutynin Chloride tablets recalled
Major Bust: Illegal Alprazolam Factories Unearthed in Pune
Crackdown on Illegal Drug Factory in Ambala Cantt: FDA Haryana Takes Swift Action
Jan Vishwas Act: Transforming Penalties for Drug Advertising Offenses
Govt Job: Unlocking Opportunities for CDSCO Recruitment 2023
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
