Drug product
Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01
D-0007-2018
Product summary
- Event
- Event 78172
- Status
- Terminated
- Classification
- Class III
- Quantity
- 128 bottles
- Official record key
drug-enforcement:D-0007-2018
Official wording
Reason: Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
Code information: Lot 754037
Distribution pattern: CO, OH
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or missing