EAST BRUNSWICK, N.J.,
May 25, 2019 /PRNewswire/
-- Heritage Pharmaceuticals Inc. ("Heritage") East Brunswick, New Jersey, is initiating a
voluntary recall of Amikacin Sulfate Injection, USP, 1g/4 mL
(250mg/mL), Lot: VEAC025, Expiry Date: October 2019 and Prochlorperazine Edisylate
Injection, USP, 10mg/2mL (5mg/mL), Lot: VPCA172, Expiry Date:
April 2020, to the consumer
level. These drug products are manufactured by Emcure
Pharmaceuticals Ltd. ("Emcure") and distributed by Heritage. The
voluntary recall is being initiated due to microbial growth having
been detected in one unreleased sublot of Lot VPCA172 and one
unreleased sublot Lot VEAC025, which may indicate a lack of
sterility in the other sublots.
Non-sterile injectable products that are intended to be sterile
may result in a site-specific or systemic infection, which in turn
may cause hospitalization, organ damage or death. To date, Heritage
has not received adverse event reports related to this event.
Amikacin Sulfate Injection is indicated in the short-term
treatment of serious infections due to susceptible strains of
Gram-negative bacteria, including Pseudomonas species, Escherichia
coli, species of indole-positive and indole-negative Proteus,
Providencia species, Klebsiella-Enterobacter-Serratia species, and
Acinetobacter (Mima-Herellea) species.
Amikacin Sulfate Injection was manufactured in a sealed vial
with a printed label affixed to the vial. Ten (10) labeled vials
were packed into a carton along with a leaflet. Fifty-six (56)
cartons were packed into one shipper box. Heritage began shipping
Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), NDC #
23155-290-42, Lot: VEAC025 on June 22,
2018, and the entire lot was distributed to wholesalers and
distributors in United States
between June 2018, and August 2018.
Prochlorperazine Edisylate Injection is indicated to control
severe nausea and vomiting and for the treatment of schizophrenia.
Prochlorperazine has not been shown effective in the management of
behavioral complications in patients with mental retardation.
Prochlorperazine Edisylate Injection was manufactured in a
sealed vial with a printed label affixed to the vial. Five
(5) labeled vials were packed into one formed PVC tray. Two (2) PVC
trays were packed into a carton along with a leaflet. Twenty (20)
cartons were packed into one shipper box. Heritage began shipping
Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), NDC #
2315529442, Lot: VPCA172, on October 31,
2018, which was distributed to wholesalers and distributors
in United States between
October 2018, and November 2018.
Qualanex is notifying Heritage consignees by recall notification
and arranging for return of the recalled product.
Consumers should contact their doctor for further guidance and
potential change of treatment before they stop taking this drug
product. Pharmacies and healthcare facilities that have the
products subject to this recall should immediately stop dispensing
this drug product and consumers should immediately stop using any
product within these specific lots.
Consumers should contact their physician or healthcare provider
if they have experienced any problems that may be related to taking
or using this drug product.
Consumers with questions regarding this recall should contact
Qualanex at 1-800-505-9291 Monday – Friday, 8:00 am – 5:00 pm, EST and or
recall@qualanex.com. Any adverse reactions or quality problems
associated with the use of this product may be reported to
ProPharma at 1-866-901-3784 at any time, and any such problems may
also be reported to FDA's MedWatch Adverse Event Reporting program
either by phone, 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.
See product labeling below for ease of identifying the
product.
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SOURCE Heritage Pharmaceuticals Inc.