FDA Recall D-0269-2021

NDAL Mfg Inc. · Monterey, CA

Class I — life-threatening Ongoing 1974 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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)

Lot / code: LOT # 2010045; Best Before 10 2023

Quantity: 4265 bottles

Reason for recall

Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast

Recall record

Recall number: D-0269-2021
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Distributed Nationwide in the USA and Hong Kong
Recall initiated: 2020-12-17
Classified by FDA Center: 2021-02-19
FDA published: 2021-03-03
Recalling firm: NDAL Mfg Inc.
Firm location: Monterey, CA

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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