Why it was recalled
Cross contamination with other products: metronidazole
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 40608, Exp 5/17
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0780-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 1, 2016
- FDA report date
- Mar 30, 2016
- Quantity
- 37,450 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sagent Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0780-2016, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 73434
- Address
- 1901 N Roselle Rd Ste 700
- Code information
- Lot #: 40608, Exp 5/17
- Postal code
- 60195-3194
- Report date
- Mar 30, 2016
- Product type
- Drugs
- Recall number
- D-0780-2016
- Classification
- Class II
- Recalling firm
- Sagent Pharmaceuticals Inc
- Product quantity
- 37,450 bags
- Termination date
- Sep 22, 2017
- Reason for recall
- Cross contamination with other products: metronidazole
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 1, 2016
- Initial firm notification
- Letter
- Center classification date
- Mar 22, 2016