Fluconazole Injection recall: Sterility Concern
Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable…
Why was Fluconazole Injection 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: A051052, Exp. Aug 2017
- Product
- Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable…
- Recalling firm
- Claris Lifesciences Inc
- Quantity
- 18,096 units (3016 cartons x 6 bags)
- Distribution
- Nationwide
- Recall date
- April 5, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)