Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Oxacillin for Injection, USP, 10 g due to presence of iron ...
17 Agosto 2016 - 4:45PM
Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT) today announced the
voluntary nationwide recall of one lot of Oxacillin for Injection,
USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017)
manufactured by Astral SteriTech Private Limited and distributed by
Sagent. Sagent has initiated this voluntary recall to the
user level due to the receipt of a product complaint for a single
vial containing small, dark particulate matter found within the
solution after reconstitution. The particulate matter has
been identified as iron oxide.
In the event that metal particulate in an
injectable product is administered to a patient, it may result in
local swelling, irritation of blood vessels or tissue, or blockage
of blood vessels. Blockage of blood vessels can lead to
serious events, which may be life-threatening, such as stroke,
heart attack, respiratory failure, kidney failure, or liver
failure.
To date, Sagent is not aware of any known
adverse patient events resulting from the use of the subject
product lot.
The product is packaged in cartons containing 10 x 10 gram
Pharmacy Bulk Package bottles identified by NDC 25021-163-99.
The lot number being recalled is Lot OXT512 which was distributed
to hospitals, wholesalers and distributors nationwide from June
2016 through July 2016. Oxacillin for Injection, USP, 10 g is
indicated in the treatment of infections caused by penicillinase
producing staphylococci which have demonstrated susceptibility to
the drug. It is available by prescription only.
Customers are being notified by fax, email, FedEx, and/or
certified mail that includes arrangements for the return of all
recalled product. Customers have been instructed to examine their
inventory immediately and to quarantine, discontinue distribution
of and return the recalled lot of product. Customers who may
have further distributed this product have been requested to
identify their customers and notify them at once of this product
recall. The necessary form by which to document this information as
well as other information regarding this recall is available at
www.sagentpharma.com.
Any questions about returning unused product should be directed
to the Customer Call Center at (866) 625-1618 M-F 8am-7pm
CDT. Healthcare workers who have medical questions about
Oxacillin for Injection, USP may contact Sagent Medical Affairs
(866-625-1618, Option 3) M-F 8am-5pm CDT.
Consumers should contact their physician or healthcare provider
if they have experienced any problems that may be related to taking
or using this product.
Adverse reactions or quality problems 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.
About Sagent Pharmaceuticals, Inc. Sagent
Pharmaceuticals, Inc., founded in 2006, is a leading provider of
affordable pharmaceuticals to the hospital market. Sagent has
created a unique, global network of resources, comprising rapid
development capabilities, sophisticated manufacturing and
innovative drug delivery technologies, resulting in an extensive
and rapidly expanding pharmaceutical product portfolio that
fulfills the evolving needs of patients.
INVESTOR CONTACT:
Jonathon Singer, Sagent
(847) 908-1605
jsinger@sagentpharma.com
CUSTOMER SUPPORT:
Customer Call Center
(866) 625-1618
SAGENT MEDICAL AFFAIRS
(866) 625-1618, Option 3
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