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Labelling error: Pharma firm recalls over a lakh saline bottles

Hindustan Antibiotics Ltd,Pimpri,a PSU struggling to revive itself,has found itself in troubled waters yet again.

Hindustan Antibiotics Ltd,Pimpri,a PSU struggling to revive itself,has found itself in troubled waters yet again. This time,it has been forced to withdraw over a lakh saline bottles from the market in what the company officials claim was a “labelling” goof-up.

Following directives from the State Food and Drug Administration (FDA),the HA management has not only recalled the bottles but also ordered a probe into the “printing mistake” which,company officials said,was a huge embarrassment at a time when it was on the revival path. Action has been initiated against three seniors officials for the act that FDA termed as “gross negligence”.

“We have ordered a probe and also initiated disciplinary action. The printing contractor has been served a notice,” said HA’s personnel manager T Das. Among the three senior officials is an assistant manager who was responsible for verifying the labels on the bottles.

HA officials,terming the incident a sabotage bid,said they suspected some private parties could be behind it as the company was re-establishing itself. “We suspect it to be the handi-work of some private parties,” said Das,adding that 1.03 lakh bottles have been recalled. The collective worth of the bottles is pegged at Rs 8 lakh.

The bottles were supplied to a government hospital in Jaipur. “No bottle has been supplied in Pune or elsewhere. After a government hospital,they were to be supplied in other hospitals. HA officials in Jaipur noticed the discrepancy in the labelling and informed us,” said Das.

The discrepancy related to the mention of words ‘5 per cent extra dextrose’. FDA joint commissioner B R Masal said,“The bottles contain 0.9 per cent sodium chloride. However,the label had ‘5 per cent extra dextrose’ written in Hindi. We inspected the company premises on July 11 and July 12 and took samples of eight batches. The samples have been sent to the Drug Control Laboratory in Mumbai for testing.”

FDA officials said it appeared to be a “labelling mistake”. Masal said they would be able to comment further only after laboratory report is available. FDA however is mincing no words in criticising the company officials. “It is gross negligence on the part of the company officials. This should not have happened.”

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HA officials said even if there is dextrose in the bottle,it is non-poisonous and not a cause for worry. “There is nothing to fear. It is only a labelling mistake,” said Das.

Asked what led to the error,Das said,“We believe that proof reading was not done properly. We make the dummy of the labels that are sent for proof reading. The errors are corrected and verified before the labels are put on the bottles. Perhaps the wrong labels were approved. The matter is being investigated thoroughly,” he said.


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