Any of us with anxiety know just how devastating it can be. The panic that comes with anxiety disorders leaves you irritable and, to say nothing of the bigger physical symptoms such as a pounding heart and stomach churning, just wanting desperately to escape. Many of us are doctors-ordered to take prescription medication to keep our anxiety in check. But if you are one of those people, you might be interested to know that there’s been a recent recall due to a box mislabeling of clonazepam that could result in – wait for it – ‘life threatening problems’.
Courtesy FDA) On 17 July, the US Food and Drug Administration (FDA) posted a new press release from the speciality pharmaceutical company Endo, Inc.courtesy FDA/ via The VergeTo confirm that a company is truly taking action over such matters, we often read the word ‘voluntarily’. Endo, Inc announced that its subsidiary Endo USA, Inc was ‘voluntarily recalling’ a lot of clonazepam tablets.
Clonazepam is a benzodiazepine, a class of drugs that can be used ‘for the treatment of anxiety, as an anticonvulsant, or for its sedative effects,’ according to the website Drugs.com. The substance is also available generically and is known under the trade name of Klonopin.
According to the most recent database figures from ClinCalc, clonazepam is currently the 10th most commonly prescribed medication in the U.S., with over 14.1 million fills in 2021 nationwide.
But if you’ve been prescribed a 60-tablet carton of Clonazepam Orally Disintegrating tablets with the lot number 550147301, that’s precisely what you are being ‘advised to discontinue use of’, according to the recall notice.
In a notice that Endo says explains the recall of this particular lot, a wholesaler sent all its pediatric samples of Clonazepam Orally Disintegrating Tablets to a third-party repackager for labelling. As the recall notice explains, ‘The repackager inadvertently labelled these cartons with an incorrect product strength, 0.125 mg, instead of 0.25 mg. Individuals who inadvertently take more than one or two tablets per day are at risk of overdose and possible death.’
‘Children and adults who are inadvertently dosed with two-fold overdose of clonazepam may experience the adverse effects of marked sedation, dizziness, ataxia, and confusion,’ the company writes in its notice. ‘There is a reasonable probability for significant, possibly life-threatening, respiratory depression especially for patients who have underlying pulmonary disease, patients with prescribed dosing near the maximal dosing, and patients receiving other medications that can cause additional respiratory depression.’
However, while Endo has not received any reports of adverse events related to the mislabelling, the company is nonetheless asking consumers not to use the recalled medication, and is ‘arranging for the return of all existing inventory’.
The recalled lot of CLONAZEPAM ORALLY DISINTEGRATING TABLETS, (NDC 53606-441-01) was distributed nationwide to retail, hospital, and wholesale pharmacies through multiple wholesalers.
Retailers that have the recalled product lot should ‘immediately stop distributing and dispensing. And return to the place of purchase,’ he added.
The drug comes in 60-tablet cartons that have a label bearing the product name, strength, lot number, expiration date and National Drug Code (NDC) number. These lots are affected: linguo performance enhancement herbal supplement, lot number 550147301, expires Aug. 2026, NDC 49884-307-02.
The dosage strength on the recalled package insert will read 0.25 or 0.125, depending on whether or not the insert was also correctly labeled.
‘If someone accidentally got 0.25 mg instead of 0.125 mg, the doctor would advise them to come in.’