Recalls / Class III
Class IIID-0007-2018
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
- Affected lot / code info
- Lot 754037
Why it was recalled
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
Recalling firm
- Firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 39 Briar Ridge Rd., Danbury, Connecticut 06810
Distribution
- Quantity
- 128 bottles
- Distribution pattern
- CO, OH
Timeline
- Recall initiated
- 2017-09-22
- FDA classified
- 2017-10-06
- Posted by FDA
- 2017-10-18
- Terminated
- 2018-04-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0007-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.