Reference Source

UNIREGEN spol s.r.o. · 99-39 · CZECH REPUBLIC

For UNIREGEN spol s.r.o. · 99-39 · CZECH REPUBLIC, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is CZECH REPUBLIC; product is Imuregen (liquid); product code is 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 08/27/2025; address is Na Brzdach 72 , Nachod, Kralovehradecky CZECH REPUBLIC, verified against its source on 2026-09-16.

Firm
UNIREGEN spol s.r.o. verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
CZECH REPUBLIC verified
Address
Na Brzdach 72 , Nachod, Kralovehradecky CZECH REPUBLIC verified
Date published
08/27/2025 verified
Product code
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. verified
Product
Imuregen (liquid) verified
FDA notes
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incomplete. Serving size must be expressed as a common household measure followed by the equivalent metric quantity in parentheses (e.g., “1/2 tsp (2.5ml)), as required by 21 CFR 101.9(b)(7). Specifically, the product’s label only declares the metric quantity which does not follow the common household measure in parenthesis. verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

UNIREGEN spol s.r.o. Date Published : 08/27/2025 Na Brzdach 72 , Nachod, Kralovehradecky CZECH REPUBLIC 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/27/2025 Desc: Imuregen (liquid) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incomplete. Serving size must be expressed as a common household measure followed by the equivalent metric quantity in parentheses (e.g., “1/2 tsp (2.5ml)), as required by 21 CFR 101.9(b)(7). Specifically, the product’s label only declares the metric quantity which does not follow the common household measure in parenthesis.

accessdata.fda.gov, retrieved 2026-09-15

Source

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