Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51
Reported: May 9, 2018 Initiated: March 27, 2018 #D-0703-2018
Product Description
Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51
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
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 395150 bags
- Distribution
- US Nationwide
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51. Recalled by AuroMedics Pharma LLC. Units affected: 395150 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 9, 2018. Severity: Moderate. Recall number: D-0703-2018.
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