All sterile products within expiry recall: Sterility Concern
All sterile products within expiry
Why was All sterile products within expiry recalled?
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
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
- Product
- All sterile products within expiry
- Recalling firm
- Unique Pharmaceutical, Ltd
- Quantity
- 325,225 units (syringes, vials, bags)
- Distribution
- Nationwide
- Recall date
- October 15, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)