HOSPIRA – WHEN IS A DRUG RECALL AN ALERT

 FDA RECOMMENDS ALERT TO AVOID DRUG SHORTAGES

In a previous Blog (May 24, 2012) the issue of Warning Letters and how the FDA now on a routine basis is asking their Clients to advise them if the Warning Letter and its consequences will result in shortages was discussed.  In this Blog, the FDA is using “Risk Management” to determine whether overfilled Carpuject pre-filled syringes (Hospira) should be reviewed by the pharmacist and other healthcare providers to visually identify the presence of an overfilled Carpuject pre-filled cartridge to determine whether it is overfilled. 

Several lots have previously been recalled in April (Morphine Sulfate, 04/18/12) and May (Hydromorphone Hydrochloride, 05/14/12) because of this issue.  However, the FDA now believes the health care professional can manage this issue.

The FDA has advised that “subsequent inspection of retained product by Hospira found additional overfilled Carpuject pre-filled cartridges.  The manufacturing problem thought to be responsible for this overfilling has resulted in the risk for overfilled Carpuject pre-filled cartridges for as many as 280 lots of 15 different Carpuject pre-filled cartridge products.”

“FDA is advising healthcare providers to follow the instructions provided with the medication and visually inspect and confirm that the Carpuject pre-filled cartridge contains the labeled fill volume before dispensing and again before administering to patients.”