Why it was recalled
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Product description
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
Lot numbers, UPCs & expiration codes
Lot # CLZ160007, Exp August 2018
Where it was sold
Product was distributed throughout United States.
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-0337-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 20, 2017
- FDA report date
- Feb 14, 2018
- Quantity
- 9,050 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0337-2018, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78800
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot # CLZ160007, Exp August 2018
- Postal code
- 08520-1401
- Report date
- Feb 14, 2018
- Product type
- Drugs
- Recall number
- D-0337-2018
- Classification
- Class I
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 9,050 bags
- Termination date
- Jun 24, 2019
- Reason for recall
- Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed throughout United States.
- Recall initiation date
- Dec 20, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2018