Recalls / Class II
Class IID-0780-2016
Product
Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82
- Affected lot / code info
- Lot #: 40608, Exp 5/17
Why it was recalled
Cross contamination with other products: metronidazole
Recalling firm
- Firm
- Sagent Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1901 N Roselle Rd Ste 700, N/A, Schaumburg, Illinois 60195-3194
Distribution
- Quantity
- 37,450 bags
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-03-01
- FDA classified
- 2016-03-22
- Posted by FDA
- 2016-03-30
- Terminated
- 2017-09-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0780-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.