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NeiMed NasoGel for DRY NOSES recallZ-1105-2025 · Neilmed Pharmaceuticals Inc · initiated Dec 28, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Neilmed Pharmaceuticals Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to nasal spray stability failure for bioburden.

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected]. 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 [email protected] and put NGS-PA in the subject for further instructions .

Recall details

Recall number
Z-1105-2025
Status
Open, Classified
Initiated by the company
Dec 28, 2024
Posted by the FDA
Feb 5, 2025
Recalling firm
Neilmed Pharmaceuticals Inc
Quantity
89,312
Product code
KCJ
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.

Product description

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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