Endo Pharmaceuticals recalls
FDA enforcement reports naming Endo Pharmaceuticals, Inc. as the recalling firm.
- Recall reports
- 5
- Class I (serious)
- 2
- Most recent report
- Aug 7, 2024
- Aug 7, 2024Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0Drug · Endo Pharmaceuticals, Inc.Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.Class I
- Apr 5, 2023Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 20…Drug · Endo Pharmaceuticals, Inc.Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.Class II
- Oct 10, 2018robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distribute…Drug · Endo Pharmaceuticals, Inc.Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."Class I
- Mar 15, 2017Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactu…Drug · Endo Pharmaceuticals, Inc.Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanksClass II
- Jun 20, 2012Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per…Drug · Endo Pharmaceuticals, Inc.Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.Class III