Import Alert 66-34
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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 # 66-34
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of All Asian Products Containing Chloramphenicol Palmitate"
Reason for Alert:
In 1986, Food and Drug Administration (FDA) received a report from the New York State Office of Professional Discipline regarding the possible retail sale in Asian American communities of a product containing chloramphenicol palmitate for use by children.
FDA investigation, in 1986, including sample collection and analysis, confirmed the sale of a product containing chloramphenicol palmitate under the brand name of "Comycin Powder for Children" by at least one retail outlet in the Rochester, New York, vicinity. Comycin is distributed in individual envelopes with both foreign and English labeling which lists chloramphenicol palmitate as an ingredient and "Thailand" as the country of origin. In 1986, label translation identified the manufacturer as "Thai Charoen Bhaesaj (Comycin) Co., Ltd. (Pharma).¿ Recently the product has been received through the mail from "Thai Development Pharmaceutical Comycin, Ltd.," 100 Seonouannoi Ekmai Street, Crounthep Metropolitan, Thailand.
Chloramphenicol is a hazardous antibiotic that is clinically indicated only for certain serious infections and it should not be used in the treatment of other or less serious infections. The Center for Drugs has confirmed that the use of chloramphenicol without the supervision of a physician would pose a danger to health.
FDA investigation, in 1986, including sample collection and analysis, confirmed the sale of a product containing chloramphenicol palmitate under the brand name of "Comycin Powder for Children" by at least one retail outlet in the Rochester, New York, vicinity. Comycin is distributed in individual envelopes with both foreign and English labeling which lists chloramphenicol palmitate as an ingredient and "Thailand" as the country of origin. In 1986, label translation identified the manufacturer as "Thai Charoen Bhaesaj (Comycin) Co., Ltd. (Pharma).¿ Recently the product has been received through the mail from "Thai Development Pharmaceutical Comycin, Ltd.," 100 Seonouannoi Ekmai Street, Crounthep Metropolitan, Thailand.
Chloramphenicol is a hazardous antibiotic that is clinically indicated only for certain serious infections and it should not be used in the treatment of other or less serious infections. The Center for Drugs has confirmed that the use of chloramphenicol without the supervision of a physician would pose a danger to health.
Guidance:
Districts may detain without sampling all "Comycin" and other Asian products containing chloramphenicol palmitate or other chloramphenicol compound; manufacturer/shippers identified in the attachmnet for this alert.
Product Description:
Comycin and other Asian Products containing Chloramphenicol Palmitate
Charge:
"The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to be a new drug without an effective new drug application as required by section 505(a);
OASIS Charge Code - UNAPPROVED
and
appears to be misbranded within the meaning of section 502(j), in that it is dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended or suggested in its labeling, and 502(f)(1), in that its labeling fails to bear adequate directions for use for its intended purpose.
OASIS Charge Code - DANGEROUS
OASIS Charge Code - UNAPPROVED
and
appears to be misbranded within the meaning of section 502(j), in that it is dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended or suggested in its labeling, and 502(f)(1), in that its labeling fails to bear adequate directions for use for its intended purpose.
OASIS Charge Code - DANGEROUS
THAILAND
Thai Charoen Bhaesaj (Comycin) Co., Ltd
Date Published : 09/10/2009
Unknown Street , Unknown, THAILAND
56 K - - 11 Chloramphenicol Palmitate (Certifiable)
Date Published: 09/10/2009
Thai Developoment Pharmaceutical Comycin Ltd.
Date Published : 09/10/2009
100 Seonouannoi Ekmai Street , Crounthep Metropolitan, THAILAND
56 K - - 11 Chloramphenicol Palmitate (Certifiable)
Date Published: 09/10/2009
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