FDA Medical Device Recalls (openFDA)
Neilmed Pharmaceuticals Inc: NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT 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.
- Recall number
- Z-1105-2025
- Recalling firm
- Neilmed Pharmaceuticals Inc
- Product
- NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT 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.
- Status
- Open, Classified
- Initiated
- 2024-12-28
- Posted
- 2025-02-05
- Terminated
- not on file
- Reason
- Due to nasal spray stability failure for bioburden.
- Root cause
- Under Investigation by firm
- Action
- 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 .
- Quantity
- 89,312
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, VA, VT, WA, and WI. The countries of Bahrain, Ireland, Malaysia, Mexico, and United Kingdom.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KCJ
- Firm FEI
- 3002998723
- Firm city
- Santa Rosa
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28