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Pfizer thyroid drug back in production after packaging prob caused a stink

By Dan Stanton , 26-Feb-2014

Thyroid hormone - Pfizer's Levoxyl drug will be back on the shelves following 'uncharacteristic odour' recall
Thyroid hormone - Pfizer's Levoxyl drug will be back on the shelves following 'uncharacteristic odour' recall

Pfizer says its hypothyroid drug Levoxyl will be available within a week after a musty smell coming from the oxygen-absorbing canister stopped production last February.

After receiving complaints about an ‘uncharacteristic odour’ linked to oxygen-absorbing canisters 12 months ago, Pfizer halted production of its synthetic thyroid hormone drug, Levoxyl (levothyroxine sodium), made at the time by its subsidiary King Pharmaceuticals in Bristol, Tennessee.

Pfizer spokesman Steve Danehy told in-Pharmatechnologist.com the firm “has corrected the issue with the oxygen-absorbing canister and has resumed manufacturing Levoxyl.”  He added Pfizer expected the drug – approved to treat hypothyroidism and certain types of goiter – to be back on the shelves on approximately March 3.

Pfizer’s Levoxyl website has kept up-to-date with the supply progress, counting down the days until the drug is once more available after an investigation began in February 2013 to discover the source of the smell, leading to a voluntary recall and halt in production.

“A thorough investigation determined that the source of the odour was an oxygen-absorbing canister that had been packaged with some bottles,” the website and a letter sent by Pfizer to healthcare providers state. “The company conducted a careful assessment and concluded that the odour was not likely to cause any adverse health consequences.”

Oxygen-absorbing canisters are used in pharma bottles to prevent oxidative degradation.

Supplying oxygen-absorbing canisters

Since the recall, the 500,000 sq ft Tennessee facility has changed hands with contract manufacturing organisation (CMO) UPM penning a deal to acquire the plant in May 2013  and to continue to manufacture Levoxyl and other drugs for the Pharma Giant for the following two years.

We contacted both Pfizer and UPM to ask for more information about the remediation of the Levoxyl line and whether they were using the same oxygen-absorbing canister supplier, but both companies did not offer comment.

We contacted a number of canister manufacturers who service the pharma industry but none were able to divulge information about clients.

However, one company that definitely did not produce the odour-causing canisters was Multisorb which, following the halt in production last year, issued a press release stating its “StabilOx Oxygen Absorbing Canisters were not the cause nor were involved with this drug product recall.”

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