FDA Drug recall D-0337-2018

Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx…

• FDA Drug
• Class I
• terminated
• Published 2018-02-14

On 2018-02-14 the FDA classified a Class I recall of Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx… by Auromedics Pharma, citing presence of Particulate Matter; white particulate matter identified as mold was found in one bag.

Read the official FDA Drug notice

Product

Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51

Reason

Presence of Particulate Matter; white particulate matter identified as mold was found in one bag

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Other recalls by Auromedics Pharma

• Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-…
  FDA Drug · Class II · 2022-11-02 · Auromedics Pharma
• Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hig…
  FDA Drug · Class II · 2022-10-26 · Auromedics Pharma
• Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Wind…
  FDA Drug · Class III · 2022-10-12 · Auromedics Pharma
• Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: Auro…
  FDA Drug · Class I · 2022-02-16 · Auromedics Pharma
• Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharm…
  FDA Drug · Class II · 2021-02-10 · Auromedics Pharma

All Auromedics Pharma recalls

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0337-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.