Medicine recalls
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| The United States: Endo expands voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling |
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The US Food and Drug Administration (FDA) announces that Endo, Inc. (“Endo”) announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets (ODT), 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 affected products added to the voluntary recall are:
- Clonazepam ODT, USP (C-IV) 2mg / NDC 49884-310-02 (lot number: 550176501, 550176601)
- Clonazepam ODT, USP (C-IV) 0.125mg / NDC 49884-306-02 (lot number: 550174101)
- Clonazepam ODT, USP (C-IV) 0.25mg / NDC 49884-307-02 (lot number: 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401)
- Clonazepam ODT, USP (C-IV) 1mg / NDC 49884-309-02 (lot number: 550145201, 550175901, 550176001, 550176201)
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-expands-voluntary-recall-clonazepam-orally-disintegrating-tablets-usp-c-iv-due-potential
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website on 18 Jul 2024.
Ends/Wednesday, Nov 20, 2024
Issued at HKT 15:30
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