Recalls / Class I
Class ID-0574-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Brand name
- Levofloxacin
- Generic name
- Levofloxacin In 5% Dextrose
- Active ingredient
- Levofloxacin
- Route
- Intravenous
- NDCs
- 55150-243, 55150-244, 55150-245
- FDA application
- ANDA206919
- Affected lot / code info
- Lot CLF160003, exp May 2018
Why it was recalled
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Eugia US LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 6,072 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-01-12
- FDA classified
- 2018-03-01
- Posted by FDA
- 2018-03-07
- Terminated
- 2020-04-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0574-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.