Why it was recalled
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Product description
Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217.
Lot numbers, UPCs & expiration codes
Lot # 151387, Exp 10/31/16
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-0610-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 18, 2016
- FDA report date
- Feb 3, 2016
- Quantity
- 3,888 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services
Original FDA data
Every field from FDA enforcement report D-0610-2016, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 73094
- Address
- 2550 John Glenn Ave
- Address (line 2)
- Suite A
- Code information
- Lot # 151387, Exp 10/31/16
- Postal code
- 43217-1188
- Report date
- Feb 3, 2016
- Product type
- Drugs
- Recall number
- D-0610-2016
- Classification
- Class II
- Recalling firm
- Amerisource Health Services
- Product quantity
- 3,888 cartons
- Termination date
- Jan 11, 2017
- Reason for recall
- Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jan 18, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 27, 2016