Endo USA, Inc., affiliated to generics and specialty branded pharmaceutical company Endo, Inc., has expanded its recall of Clonazepam Orally Disintegrating Tablets (C-IV), according to the U.S. Food and Drug Administration. The recalled drugs were mislabeled with the incorrect strength on the carton.
The agency noted that the packaging lists the legacy company Par Pharmaceutical, Inc., which previously marketed clonazepam before the product was acquired by Endo.
The recall has been expanded to include additional lots of the tablets, which are indicated alone or as an adjunct in the treatment of the Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. The durg is also indicated for the treatment of panic disorder.
The expanded recall involves Clonazepam Orally Disintegrating Tablets, with strength in USP 0.125 mg, 0.25 mg, 1 mg, and 2mg, packaged in cartons containing 60 tablets packed into 10 blister strips each containing 6 tablets, with various lot codes and National Drug Code or NDC.
The potential mislabeling shows 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 impacted product lots were distributed through wholesale distributors to retail pharmacies nationwide.
The company in mid-July had called back Clonazepam Orally Disintegrating Tablets, USP 0.25 mg as well as USP 0.125 mg, both packaged in 60-count carton, with lot 550147301 and expiration date August 2026, due to the same concern.
As per Endo's ongoing investigation, there is possibility that the recalled Clonazepam product lots contain a limited number of cartons printed with the incorrect strength and NDC code due to an error by a third-party packager. However, the blister strips and tablets inside the product pack reflect the correct strength for the lot.
Children and adults who are inadvertently prescribed a two-fold overdose of clonazepam may experience adverse effects of significant sedation, dizziness, ataxia, and confusion. Some patients may experience significant, possibly life-threatening, respiratory depression especially for those with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression.
However, Endo has not received any reports of adverse events associated with the drug recall so far.
Endo is asking distributors and retailers to immediately stop distributing and dispensing and return to the place of purchase or contact Inmar Inc., while consumers are urged to discontinue use of the product.
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