Why it was recalled
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
Product description
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
Lot numbers, UPCs & expiration codes
Lot 754037
Where it was sold
CO, OH
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0007-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 22, 2017
- FDA report date
- Oct 18, 2017
- Quantity
- 128 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0007-2018, exactly as published.
Show all FDA fields
- City
- Danbury
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 78172
- Address
- 39 Briar Ridge Rd.
- Code information
- Lot 754037
- Postal code
- 06810
- Report date
- Oct 18, 2017
- Product type
- Drugs
- Recall number
- D-0007-2018
- Classification
- Class III
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Product quantity
- 128 bottles
- Termination date
- Apr 18, 2018
- Reason for recall
- Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- CO, OH
- Recall initiation date
- Sep 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Oct 6, 2017