Why it was recalled
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Product description
Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-52
Lot numbers, UPCs & expiration codes
Lot/Batch #'s: CLF160012, CLF160014 exp July 2018; CLF170007, CLF170008, CLF170009, CLF170010, CLF170011, CLF170012, CLF170013 exp February 2019; CLF170014, CLF170015, CLF170016 exp March 2019; CLF170017, CLF170018, CLF170019, exp April 2019; CLF170020, CLF170021, CLF170022 exp May 2019; CLF170035, CLF170036, CLF170037, CLF170038 exp August 2019; CLF170048, CLF170049, CLF170050, CLF170051, CLF170052 exp September 2019
Where it was sold
US Nationwide
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-0709-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 27, 2018
- FDA report date
- May 9, 2018
- Quantity
- 308112 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0709-2018, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79772
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot/Batch #'s: CLF160012, CLF160014 exp July 2018; CLF170007, CLF170008, CLF170009, CLF170010, CLF170011, CLF170012, CLF170013 exp February 2019; CLF170014, CLF170015, CLF170016 exp March 2019; CLF170017, CLF170018, CLF170019, exp April 2019; CLF170020, CLF170021, CLF170022 exp May 2019; CLF170035, CLF170036, CLF170037, CLF170038 exp August 2019; CLF170048, CLF170049, CLF170050, CLF170051, CLF170052 exp September 2019
- Postal code
- 08520-1401
- Report date
- May 9, 2018
- Product type
- Drugs
- Recall number
- D-0709-2018
- Classification
- Class II
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 308112 bags
- Termination date
- Feb 18, 2022
- Reason for recall
- Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-52
- Distribution pattern
- US Nationwide
- Recall initiation date
- Mar 27, 2018
- Initial firm notification
- Letter
- Center classification date
- May 3, 2018