FDA Classifies First Recall As Class I
Cheryl A. Thompson
BETHESDA, MD 16 August 2012—Carpuject cartridge units in lot 12720LL of hydromorphone hydrochloride injection 2 mg/mL by Hospira Inc. are being recalled because one was found with more than the labeled volume of 1mL, the company announced Wednesday.
Lot 12720LL was among the nearly 280 lots of 15 injectable medications that Hospira said in latter May could have cartridge units with more than the labeled volume of drug. At the time, FDA told pharmacists to check each item's fill volume before dispensing the product. The agency also said health care providers should perform a second check on the fill volume before administering the product.
On Wednesday, the company said it was recalling lot 12720LL because of a "reported complaint" about one of the units having more than the labeled volume.
This is the second time this year the company has recalled hydromorphone injection in cartridge units because some may contain too much drug.
According to this week's Enforcement Report, FDA categorized the first recall, of lot 07547LL, into class I, the most serious of the three classifications of product recall.
Hospira said it determined the root cause of the manufacturing problem and has implemented measures to prevent recurrence.
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