Teva Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Amikacin Sulfate Injection USP 1 gram/4mL (250 mg/mL...
09 Mars 2016 - 7:00PM
Business Wire
Teva Pharmaceuticals today announced a voluntary recall of one
lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials
due to the potential presence of particulate matter identified as
glass in one vial. The recalled lot is:
Lot # Exp.
Date Vial Size NDC#
(Individual Pack) NDC# (Shelf
Pack) 4750915 9/2017
1 gram/4 mL(250 mg/mL)
0703-9040-01 0703-9040-03
The administration of a glass particulate, if present in an
intravenous drug, may result in local irritation or swelling in
response to the foreign material. More serious potential outcomes
would include blockage and clotting in blood vessels, which may be
life-threatening if a critical organ is affected. To date, Teva has
not received any reports of adverse events or complaints related to
this recall.
Amikacin sulfate injection USP is used in the short-term
treatment of serious infections due to susceptible strains of
Gram-negative bacteria, and has also been shown to be effective in
staphylococcal infections and may be considered as initial therapy
under certain conditions in the treatment of known or suspected
staphylococcal disease. Amikacin sulfate injection is in a class of
medications called aminoglycoside antibiotics and is packaged in
pharmacy bulk packages, containing ten 1 gram/4 mL (250 mg/mL)
vials per shelf pack. Amikacin sulfate injection 250 mg/mL, 4 mL
vials were distributed nationwide through wholesalers, retailers
and pharmacies.
Teva has issued an Urgent Drug Recall Letter to their direct
customers. Teva is arranging for impacted product to be returned to
Inmar. Anyone with an existing inventory of the recalled lot should
stop use and distribution, and quarantine the product immediately.
Customers should notify all retail and medical facility accounts.
Customers who have further distributed the recalled product should
notify any accounts or additional locations which may have received
the recalled product and instruct them if they have redistributed
the product to notify their accounts, locations or facilities.
For medical related questions please contact Teva Medical
Information at 888-838-2872, option 3, then, option 4. For a
customer service related question, please contact Teva Customer
Service at 800-545-8800 Monday – Friday; 8:00 AM – 5:00 PM EST.
Consumers should immediately contact their physician or healthcare
provider if they have experienced any problems that may be related
to taking this drug product. For product quality complaint-related
questions please contact Teva Quality Assurance Services at
888-838-2872, option 3, then, option 3.
Adverse reactions experienced with the use of this product may
be reported to the FDA's MedWatch Adverse Event Reporting program
either online, by regular mail or by fax.
- Complete and submit the report
Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download
form www.fda.gov/MedWatch/getforms.htm 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.
This recall is being conducted with the knowledge of the U.S.
Food and Drug Administration.
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version on businesswire.com: http://www.businesswire.com/news/home/20160309006118/en/
Teva PharmaceuticalsDenise Bradley,
215-591-8974denise.bradley@tevapharm.com
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