Recalls / Class III
Class IIID-1031-2018
Product
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.
- Affected lot / code info
- Lot # A061213, Exp 09/18
Why it was recalled
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Recalling firm
- Firm
- Renaissance Lakewood, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1200 Paco Way, N/A, Lakewood, New Jersey 08701-5938
Distribution
- Quantity
- 3000 bags
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2018-07-11
- FDA classified
- 2018-08-02
- Posted by FDA
- 2018-08-08
- Terminated
- 2022-03-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1031-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.