American Regent Initiates Nationwide Voluntary Recall of Epinephrine Injection, USP, 1:1000, 1mL Ampules Lot #1395 Due to Discoloration and Small Visible Particles
May 4th, 2012
The FDA has announced that 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 #0517-1071-25 Lot #1395, Exp Date: July 2012
PLEASE NOTE: This recall, initiated on April 24, 2012, 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 due to discoloration and small visible particles found in some ampules of this lot.
The product was distributed to wholesalers and distributors nationwide. 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. Please direct all questions about the return process to Customer Service at 1-877/788-3232, Monday thru Friday from 8:30 AM to 7:00 PM ET.
Any adverse reactions experienced with the use of this product should be reported to American Regent via e-mail at email@example.com, by fax to 610-650-0170, or by phone at 1-800-734-9236, Monday thru 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.
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 irritation.
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.
- Online: www.fda.gov/medwatch/report.htm
- 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.
- Fax: 1-800-FDA-0178
View the entire recall notice at: http://www.fda.gov/Safety/Recalls/ucm301783.htm