American Regent Initiates Nationwide Voluntary Recall of Epinephrine Injection, USP, 1:1000, 1 mL Am
Tuesday, April 24, 2012
American Regent Initiates Nationwide Voluntary Recall of Epinephrine Injection, USP, 1:1000, 1 mL Ampules Lot #1395 Due to Discoloration and Small Visible Particles
SHIRLEY, N.Y., April 24, 2012 /PRNewswire
via COMTEX/ -- American Regent is conducting a nationwide voluntary recall to
the Retail/Hospital level of the following product:
Epinephrine Injection, USP, 1:1000, 1 mL Ampules NDC
Lot #1395, Exp Date: July 2012
NOTE: This recall, initiated on April 24, 2012 to the Retail/Hospital Level, is
for lot #1395 only. No other lot or sizes of Epinephrine Injection, USP are
subject to this voluntary recall.
American Regent is undertaking this
voluntary recall of Epinephrine Injection, USP, lot #1395 because of
discoloration and small visible particles found in some ampules of this lot.
Potential adverse events after intravenous
administration of solutions containing particulates may include disruption of
blood flow within small blood vessels in the lung, localized inflammation
(swelling and redness), and granuloma formation. Muscle and adipose tissue
damage may occur by the intramuscular or subcutaneous injection of solutions
containing particulates. Adverse events with intra-spinal injection for this
product containing particles are unknown, but may cause inflammation. Adverse
events after topical ocular administration with Epinephrine solutions
containing particles are also unknown, but may result in ocular pain or
Hospitals, Retail Pharmacies, Clinics,
Physician Offices, and other healthcare facilities and providers should not use
American Regent Epinephrine Injection, USP, 1:1000, 1 mL ampules with lot #1395
for patient care and should immediately quarantine any product for return.
American Regent is notifying its
distributors and consumers by e-mail, facsimile, and/or overnight courier and
is arranging for return of all recalled product. Consumers/distributors/retailers
that have product which is being recalled should stop use.
American Regent will credit accounts for
all returned Epinephrine Injection, USP, 1:1000, 1 mL ampules with lot #1395.
Those with questions about the return or recall process s should contact
Customer Service at 1-877-788-3232, Monday through Friday from 8:30 AM to 7:00
Hospitals, emergency rooms, clinics, and
other healthcare facilities and providers, or patients with product quality
complaints, medical or other questions concerning the use of the product or
reasons for this recall should contact the Professional Services Department at
1-877-788-3232, Monday through Friday from 9:00 AM to 5:00 PM ET.
Any adverse reactions experienced with the
use of this product should be reported to American Regent via e-mail at firstname.lastname@example.org,
by fax to 610-650-0170, or by phone at 1-800-734-9236, Monday through Friday
from 9:00 AM to 5:00 PM ET. TO EXPEDITE HANDLING PLEASE DO NOT REPORT ANYTHING
OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS E-MAIL ADDRESS OR FAX OR PHONE.
Adverse reactions or quality problems
experienced with the use of this product/lot may be reported to the FDA's
MedWatch Adverse Event Reporting program online, by regular mail, or by fax.
Regular Mail: use postage-paid,
pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm .
Mail to address on the pre-addressed form.
While American Regent continues to
investigate this issue, the company is taking precautionary action and
initiated this voluntary recall. American Regent has informed the FDA of its
actions and is maintaining ongoing discussions with the Agency.
Epinephrine Injection, USP is manufactured
by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc.
This voluntary recall is being conducted
with the knowledge of the U.S. Food and Drug Administration.
Luitpold Pharmaceuticals, Inc.