Nivolumab 480 MG / recall: Sterility Concern
NIVOLUMAB 480 MG / 100 ML NS IVPB; NIVOLUMAB 200 mg / 100 ML NS IVPB; NIVOLUMAB 165 mg / 100 ML NS IVPB; NIVOLUMAB 240 mg / 100 ML NS IVPB, Rx Only…
Why was Nivolumab 480 MG / recalled?
Lack of Assurance of Sterility
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?
All lots within expiry
- Product
- NIVOLUMAB 480 MG / 100 ML NS IVPB; NIVOLUMAB 200 mg / 100 ML NS IVPB; NIVOLUMAB 165 mg / 100 ML NS IVPB; NIVOLUMAB 240 mg / 100 ML NS IVPB, Rx Only…
- Recalling firm
- Infusion Options, Inc.
- Quantity
- N/A
- Distribution
- NY only
- Recall date
- August 21, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)