FDA recalls antibiotic, cites error, health risk

The Food and Drug Administration (FDA) has ordered the recall of an antibiotic drug manufactured in India, citing findings that it poses “a safety risk and adverse health consequences.”

In an advisory posted on its website, the FDA said Clarithromycin (Clarie DS 250 mg/5 ml) powder for oral suspension, a product of Ind-Swift Ltd., had been recalled from the market due to a possible manufacturing error.

“Based on the result of laboratory analysis conducted by the 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,” according to the advisory signed by the agency’s acting director general, Kenneth Hartigan-Go.

‘Not a simple mislabeling’

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  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 advisory added.

“All drug retail outlets carrying all batches of Clarithromycin are ordered to discontinue selling to the consumers.”

The FDA said doctors were also being warned against prescribing these products.

The drug is imported and distributed by Ambica International Trading Corp., which holds the license for all the batches of Clarithromycin.  Niña P. Calleja