Why it was recalled
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Product description
Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46
Lot numbers, UPCs & expiration codes
Lot CLF160003, exp May 2018
Where it was sold
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-0574-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 12, 2018
- FDA report date
- Mar 7, 2018
- Quantity
- 6,072 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0574-2018, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78932
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot CLF160003, exp May 2018
- Postal code
- 08520-1401
- Report date
- Mar 7, 2018
- Product type
- Drugs
- Recall number
- D-0574-2018
- Classification
- Class I
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 6,072 bags
- Termination date
- Apr 1, 2020
- Reason for recall
- Presence of Particulate Matter; contains visible particulate matter identified as mold.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 12, 2018
- Initial firm notification
- Press Release
- Center classification date
- Mar 1, 2018