Pharmaceutical Company Recalls Panic Disorder Drug Over Mislabeling: FDA

A batch of clonazepam disintegrating tablets made by Endo USA has erroneous strength labeling that could lead to overdoses, according to an FDA announcement

The U.S. Food and Drug Administration in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

Endo USA Inc. said it’s recalling one lot of clonazepam disintegrating tablets because of mislabeled strength information. The company is warning consumers not to take the drug, according to a notice published by the U.S. Food and Drug Administration (FDA) last week.

Clonazepam, which is sometimes marketed as Klonopin, is a benzodiazepine drug that’s approved by the FDA to treat anxiety, epilepsy, and panic disorders. Off-label, the drug can be prescribed for restless leg syndrome, insomnia, and acute mania.

The single product lot of Clonazepam Orally Disintegrating tablets was recalled because of a “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,” Endo USA stated in the FDA notice.

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The blister strips inside the packaging show the correct strength of 0.25 mg, according to the notice.

Adults and children who are “inadvertently prescribed a two-fold overdose” could suffer health problems such as confusion, “significant sedation,” dizziness, and ataxia, or muscle weakness.

The company warned that the mislabeling could increase the possibility of “significant” and “possibly life-threatening” respiratory issues for individuals with concomitant pulmonary disease as well as people who are taking other medication that could cause additional respiratory depression and for people who are taking near the maximum dose of clonazepam.

The Malvern, Pennsylvania-based firm said it hasn’t received any reports of any adverse health events linked to the recalled product.

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Consumers who have any unused, prescribed 60-tablet cartons of Clonazepam Orally Disintegrating tablets, USP 0.25mg, that may also appear as Clonazepam Orally Disintegrating tablets, USP 0.125mg, should not use the product, according to the recall notice.

The packages feature the product’s name, the lot number, the expiration date, the strength, and the National Drug Code number. A review of the labels included in the announcement shows that National Drug Codes 49884-307-02 and 49884-306-02 are displayed.

Endo USA officials didn’t respond by publication time to a request by The Epoch Times for comment.

“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,” the company stated.

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The affected lot was distributed through wholesale distributors to retail pharmacies across the United States. A written notification from Endo will be provided to the wholesale companies and retailers that have received the lot, according to the company, which added that it will arrange for the return of the existing product.

“Distributors, retailers that have the product lot being recalled should immediately stop distributing and dispensing and return to the place of purchase or contact (distributor) Inmar,” the company stated.

A webpage operated by the U.S. National Library of Medicine says that clonazepam can increase the risk of life-threatening health issues such as “breathing problems, sedation, or coma if used along with certain medications.”

“Clonazepam may be habit forming. Do not take a larger dose, take it more often, or for a longer time than your doctor tells you to,” the agency also warns, adding that the medication can also cause a physical dependence.