Recalls / Class III
Class IIID-0605-2018
Product
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
- Affected lot / code info
- Lot A060644, May 2018
Why it was recalled
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Recalling firm
- Firm
- Renaissance Lakewood, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1200 Paco Way, Lakewood, New Jersey 08701-5938
Distribution
- Quantity
- 1277 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-03-02
- FDA classified
- 2018-03-23
- Posted by FDA
- 2018-04-04
- Terminated
- 2020-04-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0605-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.