Recalls / Class II
Class IID-0696-2018
Product
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
- Affected lot / code info
- Lot #: A0A0539, Exp. 05/19
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.
Recalling firm
- Firm
- Renaissance Lakewood, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1200 Paco Way, Lakewood, New Jersey 08701-5938
Distribution
- Quantity
- 1784 bags
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2018-02-21
- FDA classified
- 2018-04-24
- Posted by FDA
- 2018-04-25
- Terminated
- 2019-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0696-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.