Monday, December 9, 2013

FDA recalls antibiotic manufactured by Indian drug company

MANILA, Philippines – The Food and Drug Administration has ordered the recall of an antibiotic drug manufactured by an Indian company after it was found to pose “safety risk and adverse health consequences.”

In an advisory posted on its website, the FDA warned the public that Clarithromycin (Clarie DS 250 mg/5 ml) powder for oral suspension, an antibiotic product manufactured by Ind-Swift Limited in India, had been recalled from the market due to a possible manufacturing error.

“Based on the result of laboratory analysis conducted by FDA, the aforementioned antibiotic product with batch number CQSIC302E failed to meet the specification based on the laboratory analysis following the direction for reconstitution stated on the label,” said the advisory, which was signed by Kenneth Hartigan-Go, FDA acting director general.

Asked if it was a case of erroneous labeling, Go said in a text message: “I believe it was not a simple mislabeling but a manufacturing error that can lead to potential toxicity.”

“Clarithromycin (Clarie DS 250) being offered for sale presents a safety risk and adverse health consequences due to above limit content following the direction for reconstitution on the label of the aforementioned antibiotic product,” the FDA said.

The antibiotic drug is imported and distributed by Ambica International Trading Corp. which holds the license for all the batches of Clarithromycin.
“All drug retail outlets carrying all batches of Clarithromycin are ordered to discontinue from selling or offer for sale to the consumers,” the FDA said.
Doctors were also warned against prescribing the drug.

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