Pfizer subsidiary King Pharmaceutical pulled the hyperthyroidism drug late last month after receiving several complaints about an ‘uncharacteristic odor’ which – subsequent analysis – has linked to the oxygen-absorbing canisters packed in the 100-count and 1000-count bottles to prevent oxidative degradation.
The US drugmaker said the odour poses no risk to human health and stressed that the recall was a precautionary measure. The firm declined to say which suppliers made the problem canister when asked by in-pharmatechnologist.com, but did give us the following statement
“Of course events like this [the Levoxyl recall] are regrettable, but our priority is to ensure patient safety and we would hope that prompt action, taken in consultation with stakeholders demonstrates this commitment.”
One thing that is clear, however, is that New York, US-based packaging technology firm Multisorb Technologies is not the canister supplier involved, which it made clear in a statement issued earlier this week.
Multisorb said its own “non-toxic StabilOx Oxygen Absorbing Canisters were not the cause nor were involved with this drug product recall” and added that “substandard oxygen absorbers are a systemic issue in the [drug] industry.”
“For pharmaceutical manufacturers concerned about oxygen absorbers creating off odors and potentially contaminating their drug products, Multisorb Technologies continues to supply the pharmaceutical industry with its non-toxic StabilOx Oxygen Absorbing Canisters. StabilOx Canisters do not exhibit the unpleasant odor that initiated the recall.
"Though not the fault of the pharmaceutical manufacturers that closely adhere to regulatory requirements, recalls like this create a long-lasting, negative impact for the manufacturer as well as for the consumers that rely on the drug product."
It is unlikely Pfizer or any drugmaker that has faced similar problems – Johnson & Johnson (J&J) for example – would dispute that the negative impact of an odour-related recall can hang around like a bad smell.
But we wanted to know what, beyond sharing this viewpoint, had prompted Multisorb to issue its press release in relation to this particular recall.
A Multisorb spokeswoman told in-Pharmatechnologist.com that: “In our opinion the contaminant being released from their canister and its effects is more newsworthy than our reaction - which is simply good business sense - as we don't want our product to be confused in any way with theirs.”
Pfizer says that fixing the odour problem may take the rest of the year and that it does not anticipate restarting Levoxyl production until 2014. The drug is now included on the US Food and Drug Administration’s (FDA) list of products in short supply.