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
Reported: March 7, 2018 Initiated: January 12, 2018 #D-0574-2018
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
Reason for Recall
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 6,072 bags
- Distribution
- Nationwide
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by AuroMedics Pharma LLC. Units affected: 6,072 bags.
Why was this product recalled? ▼
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 7, 2018. Severity: Critical. Recall number: D-0574-2018.
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