Why it was recalled
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Product description
Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.
Lot numbers, UPCs & expiration codes
Lot #: A061178, A061183, A061236, Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19
Where it was sold
Nationwide USA 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-1034-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 1, 2018
- FDA report date
- Aug 15, 2018
- Quantity
- 191,256 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-1034-2018, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 80653
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: A061178, A061183, A061236, Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19
- Postal code
- 60015-4625
- Report date
- Aug 15, 2018
- Product type
- Drugs
- Recall number
- D-1034-2018
- Classification
- Class III
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 191,256 bags
- Termination date
- Jul 16, 2020
- Reason for recall
- Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Aug 1, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 3, 2018