Ondansetron 2mg/mL recall: Sterility Concern
Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0957-69
Why was Ondansetron 2mg/mL 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 Sterile Compounded Products within Expiry
- Product
- Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0957-69
- Recalling firm
- Pharmakon Pharmaceuticals, Inc.
- Quantity
- 2300
- Distribution
- Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
- Recall date
- July 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)