Class 2 Device Recall NasoGel Spray

For Immediate Release

February 05, 2025

Contact Information

Mr. Srikanth Pai
707-525-3784

Company Announcement

On 12/28/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that firm is conduct a voluntary recall due to a microbial failure found during routine stability testing and the receipt of complaints (11 reports) related to the products unpleasant odor. Through investigation, this has led to the recall of 3 lots. We started shipping these lots in April 2024.

Customer are instructed to:
Immediately examine their inventory and quarantine products subject to recall and destroy the identified lots. In addition, if the affected products have been further distributed, please identify the consumers and notify them at once of this product recall. A copy of this recall notification letter may enhance your notification to your consumers.

The firm will provide customers with a refund or product replacement at no cost.

Please send us the proof of destruction via email to quality@neilmed.com.

For any questions, contact Dinesh Patel. M F, 8:00 am - 5:00 pm PST, (707) 889-4625.

On or about 02/06/2025, the firm added a Recall Statement to it company website https://shop.neilmed.com/products/nasogel-spray that reads "Recall Notice: NeilMed is voluntarily recalling NasoGel Spray lots NGS751, NGS757, and NGS762 distributed in 2024 due to potential contamination, which may lead to symptoms similar to the flu. If your product is affected, please email questions@neilmed.com and put NGS-PA in the subject for further instructions.

NasoGel Spray

• UDI-DI/UPC code: 00705928045309
  SKU / Lot Numbers:
  
  • GSP30-2R-48-ENU-USL / NGS751
  • GSP30-0R-96-ENU-USL / NGS757 and NGS762
  • GSP30-ARA-INTL / NGS762
  • GSP30-SWE-INTL / NGS754
  • GSP30-ENG-INT / NGS755
  • GSP30-MAL-INTL / NGS756
  • GSP30-SPA-INT / NGS760 and NGS761

NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.