Why it was recalled
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # A061213, Exp 09/18
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-1031-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 11, 2018
- FDA report date
- Aug 8, 2018
- Quantity
- 3000 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Renaissance Lakewood, LLC
Original FDA data
Every field from FDA enforcement report D-1031-2018, exactly as published.
Show all FDA fields
- City
- Lakewood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80442
- Address
- 1200 Paco Way
- Code information
- Lot # A061213, Exp 09/18
- Postal code
- 08701-5938
- Report date
- Aug 8, 2018
- Product type
- Drugs
- Recall number
- D-1031-2018
- Classification
- Class III
- Recalling firm
- Renaissance Lakewood, LLC
- Product quantity
- 3000 bags
- Termination date
- Mar 9, 2022
- Reason for recall
- Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 11, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2018