Drug product
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)
D-0269-2021
Product summary
- Firm
- NDAL Mfg Inc.
- Event
- Event 87101
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 4265 bottles
- Official record key
drug-enforcement:D-0269-2021
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
Code information: LOT # 2010045; Best Before 10 2023
Distribution pattern: Distributed Nationwide in the USA and Hong Kong
Derived failure modes
-
Microbial contamination
Microbial Contamination