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
Reported: April 5, 2017 Initiated: March 10, 2017 #D-0614-2017
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
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.
Details
- Recalling Firm
- Claris Lifesciences Inc
- Units Affected
- 18,096 units (3016 cartons x 6 bags)
- Distribution
- Nationwide
- Location
- North Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Claris Lifesciences Inc. Units affected: 18,096 units (3016 cartons x 6 bags).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 5, 2017. Severity: Moderate. Recall number: D-0614-2017.
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