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Endo Expands Voluntary Recall Of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due To Potential Product Carton Strength Mislabeling
| Potential Product Description / NDC Number |
Lot # |
| Clonazepam ODT, USP (C-IV) 2mg / 49884-310-02 |
550176501 |
| 550176601 |
|
| Clonazepam ODT, USP (C-IV) 0.125mg / 49884-306-02 |
550174101 |
| Clonazepam ODT, USP (C-IV) 0.25mg / 49884-307-02 |
550142801 |
| 550142901 |
|
| 550143001 |
|
| 550143101 |
|
| 550143201 |
|
| 550143301 |
|
| 550143401 |
|
| 550147201 |
|
| 550147401 |
|
| Clonazepam ODT, USP (C-IV) 1mg / 49884-309-02 |
550145201 |
| 550175901 |
|
| 550176001 |
|
| 550176201 |
Risk Statement:
Children and adults who inadvertently consume a higher dose of clonazepam could be at increased risk for the adverse events of significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia. There is reasonable probability for significant, possibly life-threatening, respiratory depression especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression.
To date, Endo has not received any reports of adverse events associated with this product recall.
Clonazepam Orally Disintegrating Tablets are indicated alone or as an adjunct in the treatment of the Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. Additionally, the product is indicated for the treatment of panic disorder.
Package Identification:
The product is packaged in cartons containing 60 tablets packed into 10 blister strips each containing 6 tablets. The carton and each blister strip pocket are printed with the name, strength, lot number, expiration date, and NDC number. The packaging lists the legacy company Par Pharmaceutical which previously marketed clonazepam before the product was acquired by Endo.
The images below provide an example of the potential mislabeling showing the components of a package of Clonazepam Orally Disintegrating tablets, USP 2 mg lot 550176501 with a carton bearing the product description and NDC code of Clonazepam
Orally
Disintegrating
Tablets, USP 1 mg 60-count. The location of the lot number on each component of the package is shown on the photographs within this release.
Action Required:
The
product
lots were
distributed
through
wholesale
distributors
to
retail
pharmacies nationwide.
Endo is providing written notification to wholesale accounts and retailers that have received the product lots and is arranging for the return of all existing inventory through Inmar, Inc.
Distributors, retailers
that
have
the
product
lot
being
recalled should
immediately
stop distributing and dispensing and return to the place of purchase or contact Inmar on the below telephone line.
Consumers in possession of any unused prescribed tablet cartons of Clonazepam Orally Disintegrating tablets, USP bearing the above lot numbers have been advised to discontinue use of the product.
In the event that a patient inadvertently took an incorrect dose rather than the intended dose, they are advised to consult a physician.
Consumers
with
questions
regarding this
recall
can contact
Inmar
by
telephone at
855-589- 1869 (Monday through Friday, 9 a.m. to 5 p.m. ET) or by email at [email protected] .
For more information about Clonazepam Orally Disintegrating Tablets, USP, please see full Prescribing Information including BOXED WARNING available at DailyMed - CLONAZEPAM
tablet, orally disintegrating (nih).
Adverse reactions or quality problems experienced with the use of this product lot may be reported
to
the
U.S.
Food
and
Drug
Administration's
(FDA)
MedWatch
Adverse Event
Reporting program:
-
Online :
Mail: use postage-paid, pre-addressed Form FDA 3500 available at
Fax: 1-800-FDA-0178
This product lot recall is being made with the FDA's knowledge.
About
Endo
Endo is a diversified pharmaceutical company boldly transforming insights into life- enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at
or connect with us on LinkedIn .
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements including but not limited to any statements related to product recalls, mislabeling, adverse events, FDA or other regulatory actions and any other statements that refer to expected,
estimated
or
anticipated
future results
or
that
do
not
relate
solely to
historical
facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking
statements
and
other information
are
based upon
reasonable
assumptions
and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of risks, uncertainties and factors, including risks and uncertainties related to the recall and any future recalls, potential adverse events and any regulatory actions by the FDA. Endo assumes no obligation to publicly update any forward- looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with its Form S-1/A.
SOURCE Endo, Inc.
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