IA#66-34 --- 11/16/88
TYPE OF ALERT: AUTOMATIC DETENTION
PRODUCT : Comycin and other Asian Products containing Chloramphenicol
Palmitate
PROBLEM : Unapproved new drug
COUNTRY : Thailand (875)
MANUFACTURER/
SHIPPER : Thai Charoen Bhaesaj (Comycin) Co., Ltd.
Thai Development Pharmaceutical Comycin Ltd.
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); 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.
RECOMMENDING
OFFICE : HFC-131
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.
INSTRUCTIONS : Automatically detain, without sampling all "Comycin" and other
Asian products containing chloramphenicol palmitate or other
chloramphenicol compounds.
FOI : No purging is required.
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