Elevated risk U.S. Food and Drug Administration

Par Pharmaceutical Clonazepam Orally Disintegrating Tablets, USP recall: Mislabeled with the incorrect strength on the carton

Recall published 2+ years ago Last updated

Mislabeled with the incorrect strength on the carton

Par Pharmaceutical Prescription & OTC drugs — recalled prescription & otc drugsPar Pharmaceutical Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Par Pharmaceutical Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Par Pharmaceutical Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Labelling or manufacturing-practice failure

A labelling or good-manufacturing-practice failure prompted this notice. Pharmacies and patients both rely on the printed carton being right.

What the notice says: 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.

Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.

Symptoms and when to call a doctor

If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
July 16, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Par Pharmaceutical
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Clonazepam Orally Disintegrating Tablets, USP (C-IV) Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets

What the company announced

“Updated on November 21, 2024 to reflect the product expiration dates in the product table.”

MALVERN, PA, November 18, 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.

  • Potential Product Description / NDC Number: Clonazepam ODT, USP (C-IV) 2mg / 49884-310-02 · Lot #: 550176501 · Expiry date: Feb 2027
  • Potential Product Description / NDC Number: 550176601 · Lot #: Feb 2027
  • Potential Product Description / NDC Number: Clonazepam ODT, USP (C-IV) 0.125mg / 49884-306-02 · Lot #: 550174101 · Expiry date: Jan 2027
  • Potential Product Description / NDC Number: Clonazepam ODT, USP (C-IV) 0.25mg / 49884-307-02 · Lot #: 550142801 · Expiry date: Aug 2026
  • Potential Product Description / NDC Number: 550142901 · Lot #: Aug 2026
  • Potential Product Description / NDC Number: 550143001 · Lot #: Aug 2026
  • Potential Product Description / NDC Number: 550143101 · Lot #: Aug 2026
  • Potential Product Description / NDC Number: 550143201 · Lot #: Aug 2026
  • Potential Product Description / NDC Number: 550143301 · Lot #: Aug 2026
  • Potential Product Description / NDC Number: 550143401 · Lot #: Aug 2026
  • Potential Product Description / NDC Number: 550147201 · Lot #: Aug 2026
  • Potential Product Description / NDC Number: 550147401 · Lot #: Aug 2026
  • Potential Product Description / NDC Number: Clonazepam ODT, USP (C-IV) 1mg / 49884-309-02 · Lot #: 550145201 · Expiry date: Aug 2026
  • Potential Product Description / NDC Number: 550175901 · Lot #: Feb 2027
  • Potential Product Description / NDC Number: 550176001 · Lot #: Feb 2027
  • Potential Product Description / NDC Number: 550176201 · Lot #: Feb 2027

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.

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 877-890-0765 (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.gov) .

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 recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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.

Media: Investors:

Linda Huss Juan Avendano

[email protected] [email protected]

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

How this recall developed

The company posted 2 announcements about this recall on fda.gov. They are kept together on this page: the products, codes and places listed above are combined from all of them, and the announcement text comes from the most recent English version.

  1. July 16, 2024 — First announcement. Endo USA, Inc. Issues Voluntary, Nationwide Recall of One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number 550147301 Due to Mislabeling: Incorrect Strength on Product Carton Read it on fda.gov
  2. November 21, 2024 — Recall expanded. Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling Read it on fda.gov

Check your product

The notice names 15 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 550176501
  • Feb 2027
  • 550174101
  • 550142801
  • Aug 2026
  • 550145201
  • 550147301

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • Feb 2027
  • Jan 2027
  • Aug 2026
  • August 2026

Package size

Match the net weight or the piece count on the front of the pack.

  • 2 mg
  • 0.25 mg
  • 1 mg
  • 60 count

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Labelling

Par Pharmaceutical — A labelling or good-manufacturing-practice failure prompted this notice. Pharmacies and patients both rely on the printed carton being right.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. Return the affected pack to the pharmacy for a replacement from a good lot.
  3. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.
  4. If what you were dispensed does not match your prescription, call the pharmacy before taking another dose.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Remedy named in the notice: 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.

Company contact: Endo, Inc. — Consumers: Inmar, Inc., 877-890-0765 — Media: Linda Huss, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Par Pharmaceutical prescription & otc drugs recalled?

Mislabeled with the incorrect strength on the carton 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 550176501, Feb 2027, 550174101; best-by date Feb 2027 or Jan 2027. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.

Can I get my money back?

The notice says: 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.

Where was the recalled product sold?

It was distributed nationwide.

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