Recall StatusOpen, Classified
Date Initiated2024-12-28
Product Quantity89,312
Reason for Recall
Due to nasal spray stability failure for bioburden.
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
[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 .
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.