Labeling: Label Mix-up
Boehringer Ingelheim Pharmaceuticals
Subpotent Drug
An extraneous peak was observed for dissolution testing.
An extraneous peak was observed for dissolution testing.
An extraneous peak was observed for dissolution testing.
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Failed Dissolution Specifications: OOS resultsduring routine stability testing
Cross Contamination With Other Products:
Failed Stability Specifications
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
Class I - Dangerous
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Class I - Dangerous
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.