All articles tagged with #labeling error
Originally Published 6 months ago — by fda.gov
Mondelēz Global LLC has voluntarily recalled certain sizes of RITZ Peanut Butter Cracker Sandwiches due to a labeling error that could cause allergic reactions in peanut-sensitive individuals, with no reported injuries so far.
Originally Published 1 year ago — by TODAY
Endo, Inc. has issued a nationwide recall of Clonazepam Orally Disintegrating Tablets due to a labeling error that could lead to potentially fatal overdoses. The error, made by a third-party packager, involves incorrect strength and National Drug Code on some cartons, though the blister strips and tablets are correctly labeled. The mislabeled drugs pose a risk of life-threatening respiratory depression, especially for vulnerable patients. Consumers are advised to stop using the affected tablets and consult a doctor if they have taken the wrong dose.
Originally Published 2 years ago — by FDA.gov
Teva Pharmaceuticals USA has issued a voluntary nationwide recall of specific lots of Fentanyl Buccal Tablets CII due to a labeling error that omitted safety updates in the Product Insert/Medication Guide. The recall was initiated exclusively for Mayne Pharma Inc. under Mayne’s label. The main safety concern is a potential for incomplete information needed by health care providers and patients regarding safe use of the product. The likelihood of harm occurrence is considered remote, and to date, Teva has not received any complaints related to the product labeling.