Clonazepam FDA Alerts

Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling

November 19, 2024 -- Endo, Inc. (OTCQX: NDOI) (“Endo”) announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall 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 to an error by a third-party packager. The blister strips and tablets inside the product pack reflect 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.

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 below.

Carton front and blister pack:

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 rxrecalls@inmar.com.

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.gov).

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: 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.

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 www.endo.com 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: FDA

Endo USA, Inc. Issues Recall of One Lot of Clonazepam Orally Disintegrating Tablets Due to Mislabeling: Incorrect Strength on Product Carton

MALVERN, PA, July 16, 2024 – Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125 tablets 60-count pack to the consumer level.

The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125 mg and not 0.25 mg due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25 mg.

Risk Statement: Children and adults who are inadvertently prescribed a two-fold overdose of clonazepam would be at risk for the adverse effects of significant sedation, dizziness, ataxia, and confusion. 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 lot recall.

Clonazepam Orally Disintegrating Tablets are indicated alone for 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. The product is packaged in cartons of 60 tablets; the package labels feature the product name, strength, lot number, and expiration date, and the National Drug Code (NDC) number 49884-307-02; impacted units will display the NDC code 49884-306-02.

This recall impacts the following product lot:

• See below image of correct carton label: Clonazepam Orally Disintegrating Tablets, USP 0.25 mg 60-count carton, lot 550147301, expiration date August 2026
• See below image of incorrect carton label: Clonazepam Orally Disintegrating Tablets, USP 0.125 mg 60-count carton, lot 550147301, expiration date August 2026

The product lot was distributed through wholesale distributors to retail pharmacies nationwide. Endo is providing written notification to wholesale accounts and retailers that have received product lot 550147301 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 60 tablet cartons of Clonazepam Orally Disintegrating tablets, USP 0.25mg which may also appear as Clonazepam Orally Disintegrating tablets USP 0.125mg bearing the lot number 550147301 have been advised to discontinue use of the product.

In the event that a patient inadvertently took a 0.25 mg dose rather than the intended 0.125 mg dose, they are advised to consult a physician

Consumers with questions regarding this recall can contact Inmar by telephone at 877-890- 0765 (Monday through Friday, 9 a.m. to 5 p.m. ET) or by email at rxrecalls@inmar.com.

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
• Regular Mail or Fax: Download form 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 product lot recall is being made with the FDA’s knowledge.

About Endo
Endo is a diversified specialty 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.com or connect with us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements including any statements related to the product lot recall, adverse events, regulatory actions by the FDA and any 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," "intends," "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.

Source: FDA

Drug Safety Communication: Benzodiazepine Drug Class - Boxed Warning Updated to Improve Safe Use

ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class. The FDA is also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.

Other changes are also being required to several sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.

BACKGROUND: Benzodiazepines are a class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder.

RECOMMENDATION:

Health Care Professionals

• Consider the patient’s condition and the other medicines being taken, and assess the risk of abuse, misuse, and addiction.
• Limit the dosage and duration of each medicine to the minimum needed to achieve the desired clinical effect when prescribing benzodiazepines, alone or in combination with other medicines.
• Use a gradual taper to reduce the dosage or to discontinue benzodiazepines to reduce the risk of acute withdrawal reactions.
• Take precautions when benzodiazepines are used in combination with opioid addiction medications.

Patients, Parents, and Caregivers

• Always tell your health care professionals about all the prescription and over-the-counter (OTC) medicines you are taking or any other substances you are using, including alcohol.
• Take benzodiazepines and all medicines exactly as prescribed by your health care professional
• Discuss a plan for slowly decreasing the dose and frequency of your benzodiazepine(s) with your health care professional.
• Contact your health care professional if you experience withdrawal symptoms or your medical condition worsens.
• Go to an emergency room or call 911 if you have trouble breathing or other serious side effects such as seizures.

Patients and health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

Source: FDA