IA #29-01, 3/23/00 - IMPORT ALERT #29-01, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF MANDARIN ORANGE FLOAT DRINK FOR LEAD"
This import alert represents the Agency's current guidance to FDA field
personnel regarding the manufacturer(s) and/or product(s) at issue. It does
not create or confer any rights for, or on any person, and does not operate to
bind the FDA or the public.
TYPE OF ALERT: Detention Without Physical Examination
PRODUCT: Mandarin Orange Float Drink
PROBLEM: Contains Lead
PAF: MET
PAC: 04019A
COUNTRY: Republic of Korea (South Korea) (KR)
MANUFACTURER/
SHIPPER: Nam Aujan & Bros.
Suite 328-702,
Orun-Dongsongpa-Ku
Seoul, Korea 138151
FEI# 3001604119
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to contain a poisonous
and deleterious substance (i.e., lead) which may render it
injurious to health. [Adulterated 402(a)(1)]." (OASIS
CHARGE: POISONOUS)
RECOMMENDING
OFFICE: Los Angeles District
REASON
FOR ALERT: Canned Mandarin Orange Float drink from Korea (Ligo brand,
Mandarin Orange Float) contained elevated levels of lead (49-64
ppb). The source of this lead appeared to be the tin liner which
has undergone severe corrosion. Considering that the "use by date"
is in 2001, the product could be expected to be far more degraded
at the end of the shelf life. FDA's analysis indicates the lead
exposure from this product (8 oz.) could result in an intake in
excess of the Provisional Total Tolerable Intake of Lead for
children.
GUIDANCE: Districts may detain without physical examination (DWPE) all
shipments of Mandarin Orange Float drink in cans from Nam
Aujan & Bros.
FOI: No purging required.
KEYWORDS: Mandarin Orange Float Drink, Lead, Nam Aujan
PREPARED BY: Fredda Shere-Valenti, DIOP, HFC-170
(301) 443-6553
DATE LOADED
INTO FIARS: March 23, 2000
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