Endo,Inc.(OTCQX:NDOI)(“Endo”)announcedtodaythatone ofitsoperatingsubsidiaries,EndoUSA,Inc.,is expanding its previously announced voluntaryrecall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling.
Specifically, Endo’s ongoing investigation has identified the possibility that the Clonazepam product lots listed below contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC) code due toanerrorbyathird-partypackager.Theblister stripsand tablets insidetheproductpackreflect the correct strength for the lot.
The following table details the lots being added to the voluntary recall, including lot product description and NDC number.
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 ClonazepamOrallyDisintegratingTablets, 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.
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Action Required:Theproductlots weredistributedthroughwholesaledistributorstoretailpharmacies 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, retailersthathavetheproductlotbeingrecalled shouldimmediatelystop 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.
Consumerswithquestionsregarding thisrecallcan contactInmarbytelephone at855-589- 1869 (Monday through Friday, 9 a.m. to 5 p.m. ET) or by email at rxrecalls@inmar.com.
For more information about Clonazepam Orally Disintegrating Tablets, USP, please see full Prescribing Information including BOXED WARNING available at DailyMed – CLONAZEPAMtablet, orally disintegrating (nih.gov).
Adverse reactions or quality problems experienced with the use of this product lot may be reportedtotheU.S.FoodandDrugAdministration’s(FDA)MedWatchAdverse EventReporting program:
— Online: www.fda.gov/medwatch/report.htm
— Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm
— Fax: 1-800-FDA-0178
This product lot recall is being made with the FDA’s knowledge.
AboutEndoEndo 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 www.endo.comor connect with us on LinkedIn.
Cautionary Note Regarding Forward-Looking StatementsThis 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,estimatedoranticipatedfuture resultsorthatdonotrelatesolely tohistoricalfacts. 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-lookingstatementsandother informationarebased uponreasonableassumptionsand 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.
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