FDA recall record

Mylan Pharmaceuticals DrNatura Toxinout Kit Broad Spectrum Detoxification Program recall — FDA F-0859-2019

Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 DrNatura Flora Protect Probiotics lot 3020068…

Class IIclassification
F-0859-2019official record ID
Feb 20, 2019report date

Recall record at a glance

Official recordF-0859-2019
CategoryFood Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmMylan Pharmaceuticals Inc.
Report dateFeb 20, 2019
Recall initiation dateDec 10, 2018
Quantity800 Kits
LocationMorgantown, WV, United States

Official product description

DrNatura Toxinout Kit Broad Spectrum Detoxification Program

Why the product was recalled

Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 DrNatura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 and Item# 46017-088-18 DrNatura Toxinout Kit lot 005983-001 Expiry Dec 2018 . The products are being recalled due to undeclared soy allergen statement.

Distribution information

US Market

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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