Home / Recalls / Renaissance Lakewood, LLC / D-0696-2018

D-0696-2018 Class II Terminated

Recalled by Renaissance Lakewood, LLC — Lakewood, NJ

Recall Details

Product Type
Drugs
Report Date
April 25, 2018
Initiation Date
February 21, 2018
Termination Date
August 14, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1784 bags

Product Description

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India 382213, NDC 36000-002-10

Reason for Recall

Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.

Distribution Pattern

Product was distributed throughout the United States.

Code Information

Lot #: A0A0539, Exp. 05/19

Other recalls by Renaissance Lakewood, LLC

  • D-1033-2018 Class III — Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 m (July 11, 2018)
  • D-1032-2018 Class III — Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 m (July 11, 2018)
  • D-1031-2018 Class III — Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 m (July 11, 2018)
  • D-0605-2018 Class III — Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexibl (March 2, 2018)
  • D-0124-2018 Class III — Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (November 11, 2017)