Teva Pharmaceuticals Initiates Voluntary Nationwide Recall of Seven Lots of Amikacin Sulfate Injection USP 500mg/2 mL (250 mg...
July 29 2016 - 9:00AM
Business Wire
Teva Pharmaceuticals today announced a voluntary recall of seven
lots of Amikacin Sulfate Injection USP, 500 mg/2mL (250 mg/mL) and
1 gram/4mL (250 mg/mL) vials due to the potential for the presence
of glass particulate matter. The recalled lots are:
Lot # Exp. Date Strength
Vial Size
NDC#(IndividualPack)
NDC#(Shelf Pack –carton
of 10vials)
2381114 11/2016
1 gm/4 mL(250 mg/mL)
4 mL 0703-9040-01
0703-9040-03 2771114 11/2016
1 gm/4 mL(250 mg/mL)
4 mL 0703-9040-01
0703-9040-03 4760915 9/2017
1 gm/4 mL(250 mg/mL)
4 mL 0703-9040-01
0703-9040-03 7080315 3/2017
500 mg/2 mL(250 mg/mL)
2 mL 0703-9032-01
0703-9032-03 7400315 3/2017
500 mg/2 mL(250 mg/mL)
2 mL 0703-9032-01
0703-9032-03 7410315 3/2017
500 mg/2 mL(250 mg/mL)
2 mL
0703-9032-01 0703-9032-03
7980415 4/2017
500 mg/2 mL(250 mg/mL)
2 mL 0703-9032-01
0703-9032-03
Serious health consequences may arise from the inadvertent
administration of glass particles. 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 belongs to a
class of medications called aminoglycoside antibiotics and is
supplied as 2 mL and 4 mL vials packaged in shelf pack of 10 500
mg/2 mL (250 mg/mL) and 1gram/4 mL (250 mg/mL) vials. Amikacin
Sulfate Injection 250 mg/mL, 2 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(s)
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 Teva Pharmaceuticals at 1-888-838-2872, option 3,
then option 4. Adverse Events or product quality issues experienced
with this product can also 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160729005434/en/
Media:Teva PharmaceuticalsDenise Bradley,
215-591-8974denise.bradley@tevapharm.com
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Apr 2023 to Apr 2024