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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: A0A0539, Exp. 05/19
Where it was sold
Product was distributed throughout the United States.
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-0696-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 21, 2018
- FDA report date
- Apr 25, 2018
- Quantity
- 1784 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Renaissance Lakewood, LLC
Original FDA data
Every field from FDA enforcement report D-0696-2018, exactly as published.
Show all FDA fields
- City
- Lakewood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79580
- Address
- 1200 Paco Way
- Code information
- Lot #: A0A0539, Exp. 05/19
- Postal code
- 08701-5938
- Report date
- Apr 25, 2018
- Product type
- Drugs
- Recall number
- D-0696-2018
- Classification
- Class II
- Recalling firm
- Renaissance Lakewood, LLC
- Product quantity
- 1784 bags
- Termination date
- Aug 14, 2019
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Feb 21, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 24, 2018