Reported Apr 25, 2018 · Terminated
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx…
Renaissance Lakewood, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Renaissance Lakewood, LLC · 1200 Paco Way · Lakewood, NJ · 08701-5938
Is this the product you have?
- Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only
- Manufactured forClaris Lifesciences Inc., North Brunswick, NJ 08902
- ByClaris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India 382213, NDC 36000-002-10
- Lot codes and dates
Lot #: A0A0539Exp. 05/19
- Amount recalled
- 1784 bags
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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