Import Alert 31-03
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 31-03
Published Date: 10/11/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Guanabana (Soursop)"
Reason for Alert:
In February 1990, thirty-four adults and children drank "Rain Drop" Guanabana Drink from Mexico and within 15 minutes they began vomiting. Dallas district laboratory performed microscpic examination of the product and found some seed cells in all "suspect" codes examined. The literature indicates the seeds are toxic and an oil expressed from the seeds has been used as an insecticide and fish poison. According to the Mexican authorities, the product is only manufactured for exportation and not consumed in Mexico.
In February 1993,a sample of Iberia brand soursop nectar( guanabana) from the Dominican Republic was recalled (already on domestic status) due to the presence of the toxic guanabana seeds.
In February 1993,a sample of Iberia brand soursop nectar( guanabana) from the Dominican Republic was recalled (already on domestic status) due to the presence of the toxic guanabana seeds.
Guidance:
Districts may detain without physical examination all shipments of guanabana (soursop) drinks, juices, nectars, etc. from manufactures /shippers in the Red List. Increase surveillance of this product from other countries. Samples collected for analysis should be forwarded to the following laboratories:
Northeast, Mid-Atlantic and Southwest regions to Southeast Regional Laboratory
Midwest and Southwest regions to Dallas, Pacific Region to Los Angeles Laboratory
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
Northeast, Mid-Atlantic and Southwest regions to Southeast Regional Laboratory
Midwest and Southwest regions to Dallas, Pacific Region to Los Angeles Laboratory
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
Product Description:
Guanabana (Soursop) drinks, juices, nectars, etc.
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 which may render it injurious to health [Adulteration, Section 402(a)(1)]."
OASIS charge code - POISONOUS
OASIS charge code - POISONOUS
DOMINICAN REPUBLIC
Caribex Dominicana SA
Date Published : 09/18/2009
Apartado 409-2 , Santo Domingo, DOMINICAN REPUBLIC
20 S - - 99 Core Fruit Juices or Concentrates, N.E.C.
Date Published: 09/18/2009
Desc:guanabana; soursop
Notes:toxic material from the fruit seed was incorporated into the finished product during the manufacturing process
Notes:toxic material from the fruit seed was incorporated into the finished product during the manufacturing process
22 I - - 04 Soursop (Other Fruit Purees)
Date Published: 09/18/2009
Desc:guanaban
Notes:toxic material from the fruit seed was incorporated into the finished product during the manufacturing process
Notes:toxic material from the fruit seed was incorporated into the finished product during the manufacturing process
Goya Santo Domingo SA
Date Published : 09/18/2009
Km 17 Ave 6 De Noviembre , San Cristobal, DO-21 DOMINICAN REPUBLIC
20 S - - 99 Core Fruit Juices or Concentrates, N.E.C.
Date Published: 09/18/2009
Notes:Guanabana Fruit Beverage; 11/20/07; toxic material from the fruit seed was
incorporated into the finished product during the manufacturing process
MEXICO
Jugos Del Valle S A. De C.V.
Date Published : 09/18/2009
Ave. Insurgentes No. 30 , Barrio De Texcacoa , Tepotzotlan, Mex MEXICO
20 S - - 99 Core Fruit Juices or Concentrates, N.E.C.
Date Published: 09/18/2009
Notes:Guanabana drink; toxic material from the fruit seed was incorporated into the
finished product during the manufacturing process
22 K - - 04 Soursop, Juice, Other Fruit Juices or Concentrates
Date Published: 09/18/2009
Notes:toxic material from the fruit seed was incorporated into the finished
product during the manufacturing process
PHILIPPINES
Profood International Corporation
Date Published : 09/18/2009
653 Highway Maguikay , No. 7 Gochan Compound , Mandaue City, Ph-Ceb PHILIPPINES
20 U - - 99 Core Fruit Purees, N.E.C.
Date Published: 09/18/2009
Notes:Aseptic guyabana (sic) Puree; toxic material from the fruit seed was
incorporated into the finished product during the manufacturing process
22 I - - 04 Soursop (Other Fruit Purees)
Date Published: 09/18/2009
Notes:toxic material from the fruit seed was incorporated into the finished
product during the manufacturing process
Summer Fruit Inc (Factory), Marsman-Drysdale Group
Date Published : 09/18/2009
Km 42 By Pass, Bgy, San Vicente , Silang , Cavite, PHILIPPINES
20 S - - 99 Core Fruit Juices or Concentrates, N.E.C.
Date Published: 09/18/2009
Notes:Guanabana; toxic material from the fruit seed was incorporated into the
finished product during the manufacturing process
22 K - - 04 Soursop, Juice, Other Fruit Juices or Concentrates
Date Published: 09/18/2009
Notes:toxic material from the fruit seed was incorporated into the finished
product during the manufacturing process
Summer Fruit Inc (Mfr), Marsman-Drysdale Group.
Date Published : 09/18/2009
Marsman Bldg, Sen Gil J Puyat Ave , Cor Washington Street, Makati , Metro Manila, PHILIPPINES
20 S - - 99 Core Fruit Juices or Concentrates, N.E.C.
Date Published: 09/18/2009
Notes:Guanabana; toxic material from the fruit seed was incorporated into the
finished product during the manufacturing process
22 K - - 04 Soursop, Juice, Other Fruit Juices or Concentrates
Date Published: 09/18/2009
Notes:toxic material from the fruit seed was incorporated into the finished
product during the manufacturing process
VIETNAM
Agrimexco
Date Published : 09/18/2009
176 Hai Ba Trung St , District 1 , Ho Chi Minh City, VIETNAM
22 H - - 04 Soursop, Dried or Paste
Date Published: 09/18/2009
Notes:4/23/01; toxic material from the fruit seed was incorporated into the finished
product during the manufacturing process
Lucky Shing Enterprise Co Ltd
Date Published : 09/18/2009
108/1 Tinh Lo 830, Hamlet 03 , An Thanh Village , Ben Luc District, Long An Province VIETNAM
22 H - - 04 Soursop, Dried or Paste
Date Published: 09/18/2009
Notes:4/11/01; toxic material from the fruit seed was incorporated into the finished
product during the manufacturing process; frozen soursop paste
22 I - - 04 Soursop (Other Fruit Purees)
Date Published: 09/18/2009
Notes:4/11/01; frozen soursop paste; toxic material from the fruit seed was
incorporated into the finished product during the manufacturing process
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