Why it was recalled
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544
Product description
Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01
Lot numbers, UPCs & expiration codes
Lot #142588, Exp 01/2016
Where it was sold
Nationwide and Puerto Rico
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-1589-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 1, 2014
- FDA report date
- Sep 24, 2014
- Quantity
- 137,300 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1589-2014, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 68779
- Address
- 2550 John Glenn Ave
- Address (line 2)
- Suite A
- Code information
- Lot #142588, Exp 01/2016
- Postal code
- 43217-1188
- Report date
- Sep 24, 2014
- Product type
- Drugs
- Recall number
- D-1589-2014
- Classification
- Class I
- Recalling firm
- American Health Packaging
- Product quantity
- 137,300 tablets
- Termination date
- Aug 3, 2015
- Reason for recall
- Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 1, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 18, 2014