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RecallWatchMedical Device Safety
Class IIOngoingZ-1105-2025

Neilmed Pharmaceuticals Inc recalls NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GS…

Neilmed Pharmaceuticals IncSanta Rosa, CA, United StatesReported Feb 12, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Due to nasal spray stability failure for bioburden.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    16 affected lots
    GSP30-2R-48-ENU-USLNGS751GSP30-0R-96-ENU-USLNGS757NGS762GSP30-ARA-INTLNGS762GSP30-SWE-INTL
    +8 moreNGS754GSP30-ENG-INTNGS755GSP30-MAL-INTLNGS756GSP30-SPA-INTNGS760NGS761

What the firm 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 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 .

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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