Hospira recalls drug due to storage hiccup
pharmafile | October 13, 2014 | News story | Manufacturing and Production, Sales and Marketing | FDA, Hospira, Vancocin, Vancomycin hydrochloride, lilly
Hospira has issued a recall of one lot of its injectable vancomycin hydrochloride in the US due to ‘uncontrolled storage during transit’.
The US firm says that it believes a shipment of the drug may have experienced temperature excursions on its way to a customer. The lot in question was then further distributed to patients.
A lack of information on the effects of uncontrolled temperatures on vancomycin means that a meaningful medical risk assessment cannot be performed, but in a statement Hospira says that there have been no adverse events or complaints reported and that they are issuing the recall “out of an abundance of caution”.
Medical facilities and pharmacies are being asked to stop distribution of the product and quarantine it immediately, and to notify all people who may be using it. The firm adds that the recall is being conducted with the knowledge of the FDA.
Vancomycin hydrochloride, originally marketed by Eli Lilly as Vancocin, is used to treat certain types of bacterial infections in the gastrointestinal tract and is sold as an injectable generic by Hospira.
Hospira was in fact formed when Abbot spun-off its hospital products division and is now the world’s largest provider of injectable generic pharma products and infusion therapy technologies.
This recall is another setback for the company, which has had to answer many questions from the FDA about practices at its plants across the world over the last few years.
Only two weeks ago it was issued a warning letter by the regulator for failing to adequately investigate and correct discrepancies and failures in products made at its Australian plant, specifically in failing to find the cause of out-of-specification results for the cancer drug mitoxantrone.
The FDA also says that there was a significant delay between claims of particles appearing in the chemo drug carboplatin and Hospira waning providers.
In the next few days the firm will have to notify the FDA of the steps it has taken to address the problems at its Australian facility.
George Underwood
Related Content
FDA approves AbbVie’s Skyrizi for UC treatment
AbbVie has announced that the US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) …
FDA approves Merck’s Capvaxive for prevention of pneumococcal disease
Merck, known as MSD outside of the US and Canada, has announced that the US …
FDA accepts Eisai’s Leqembi sBLA for early AD treatment
Eisai and Biogen have announced that the US Food and Drug Administration (FDA) has accepted …
