Why it was recalled
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Product description
Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06
Lot numbers, UPCs & expiration codes
Lot #: A051052, Exp. Aug 2017
Where it was sold
Nationwide
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-0614-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 10, 2017
- FDA report date
- Apr 5, 2017
- Quantity
- 18,096 units (3016 cartons x 6 bags)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Claris Lifesciences Inc
Original FDA data
Every field from FDA enforcement report D-0614-2017, exactly as published.
Show all FDA fields
- City
- North Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76733
- Address
- 1445 US Highway 130
- Code information
- Lot #: A051052, Exp. Aug 2017
- Postal code
- 08902-3100
- Report date
- Apr 5, 2017
- Product type
- Drugs
- Recall number
- D-0614-2017
- Classification
- Class II
- Recalling firm
- Claris Lifesciences Inc
- Product quantity
- 18,096 units (3016 cartons x 6 bags)
- Termination date
- Sep 18, 2020
- Reason for recall
- Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 10, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 24, 2017