Reported Apr 4, 2018 · Terminated
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured…
Renaissance Lakewood, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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?
- Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only
- Manufactured forClaris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
- Lot codes and dates
Lot A060644May 2018
- Amount recalled
- 1277 bags
Where it was sold
- Nationwide
Why it was recalled
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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