Hospira Carpuject Pre-filled Cartridges – Drug Alert: Products May Contain More Than the Intended F
Friday, May 11, 2012
Hospira Carpuject Pre-filled Cartridges – Drug Alert: Products May Contain More Than the Intended Fill Volume
ISSUE: FDA is alerting healthcare providers of a
potential safety risk in some Carpuject pre-filled cartridges manufactured by
Hospira, Inc. The pre-filled cartridges containing the products listed in the
Drug Alert may be overfilled by at least twice the expected amount, resulting
in potential overdose.
Because pharmacists and other healthcare
providers can visually identify the presence of an overfilled Carpuject
pre-filled cartridge, FDA is recommending that these steps be taken at this
time rather than a product recall, because a recall of the affected products
would result in an immediate shortage.
BACKGROUND: Hospira, Inc. has informed the FDA of the
occurrence of overfilled Carpuject pre-filled cartridges containing morphine
and hydromorphone following complaints received from healthcare providers.
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.
RECOMMENDATION: 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.
Healthcare professionals and patients are encouraged to report adverse events
or side effects related to the use of these products to the FDA's MedWatch
Safety Information and Adverse Event Reporting Program:
and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088
to request a reporting form, then complete and return to the address on
the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including
links to the drug alert and instructions for health professionals, at:
U.S. Food and Drug Administration (FDA)