CMO issues persist as Cubist announces third recall for potential glass in antibiotic

By Zachary Brennan contact

- Last updated on GMT

The latest recall includes more than 100 lots of the injectable
The latest recall includes more than 100 lots of the injectable
For the third time since last August, Cubist Pharmaceuticals has recalled lots of its antibiotic Cubicin injection due to the potential of glass particulates in a manufacturing line produced by an unnamed CMO (contract manufacturing organization).

The latest recalls of more than 100 lots of the injectable with expiration dates ranging from August to May 2016, follow recalls from last August​, April and now last week.

Cubist spokeswoman Julie DiCarlo told us, “This is related to the earlier recalls. The lots being recalled now represent all remaining lots produced on the line at issue. We suspended production on the line at the time of the first recall, however these lots were produced prior​.”

Although DiCarlo refused to name the CMO which had to suspend production on one of its lines, the US manufacturer label discloses the dose manufacturers as OSO Bio and Hospira.

No Complaints

No complaints of glass in vial or adverse events in association with a product complaint of glass in vial have been reported to date for these recalled lots​,” Cubist said.

Indicated for the treatment of skin infections and certain blood stream infections, Cubicin is Cubist’s main source of revenue, with revenue of the product most recently increasing 3% to $234.7m in Q2 2014, compared with $227.1m in Q2 2013.

While there have been no reported complaints regarding glass in vials in these recalled lots and no adverse events related, we're recalling these final lots out of an abundance of caution​,” DiCarlo told us. The Lexington, MA, company also said it does not expect the CMO snafu to cause a shortage of Cubicin.

Investors seem unfazed by this latest recall as Cubist’s stock has remained relatively flat over the past week.

Related topics: Regulatory & Safety, QA/QC

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