Why it was recalled
Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
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)
Lot numbers, UPCs & expiration codes
LOT # 2010045; Best Before 10 2023
Where it was sold
Distributed Nationwide in the USA and Hong Kong
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0269-2021
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Dec 17, 2020
- FDA report date
- Mar 3, 2021
- Quantity
- 4265 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- NDAL Mfg Inc.
Original FDA data
Every field from FDA enforcement report D-0269-2021, exactly as published.
Show all FDA fields
- City
- Monterey
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 87101
- Address
- 23745 Spectacular Bid Ln
- Code information
- LOT # 2010045; Best Before 10 2023
- Postal code
- 93940-6527
- Report date
- Mar 3, 2021
- Product type
- Drugs
- Recall number
- D-0269-2021
- Classification
- Class I
- Recalling firm
- NDAL Mfg Inc.
- Product quantity
- 4265 bottles
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
- Voluntary / mandated
- Voluntary: Firm initiated
- 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)
- Distribution pattern
- Distributed Nationwide in the USA and Hong Kong
- Recall initiation date
- Dec 17, 2020
- Initial firm notification
- Center classification date
- Feb 19, 2021