It appears that the communications pause is mostly lifted, but by request I will continue these updates for now.
Food and Drug Recall summary
Medical Device Recall
Date Posted: February 05, 2025
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.
Code Information 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
Recalling Manufacturer Neilmed Pharmaceuticals Inc
601 Aviation Blvd
Santa Rosa CA 95403-1025
For Additional Information Contact Mr. Srikanth Pai
707-525-3784
Manufacturer Reason: for Recall Due to nasal spray stability failure for bioburden.
FDA Determined Cause 2 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 in Commerce 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.
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THANK YOU 💖
Thank you for this. I have the spray but not that lot. Appreciate your work.