D-0269-2021 Class I Ongoing
FDA drug recall D-0269-2021 was initiated by NDAL Mfg Inc. on Dec 17, 2020 and is designated Class I. Reason for recall: Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast The recall status is ongoing. Affected quantity: 4265 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 3, 2021
- Initiation Date
- Dec 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4265 bottles
Product description
ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 measured sprays, Distributed by Ndal Laboratories, 449 Alvarado St., Monterey, CA 93940 (bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8. the Alvarado St. is for the bottle by putting "(bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8." (according to the label)
Reason for recall
Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
Distribution pattern
Distributed Nationwide in the USA and Hong Kong
Code information
LOT # 2010045; Best Before 10 2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0269-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026