Proplete 34 recall: Sterility Concern
Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4…
Why was Proplete 34 recalled?
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
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?
Compounding Date: 4/25/13 Discard after: 5/16/13
- Product
- Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4…
- Recalling firm
- Pentec Health
- Quantity
- 1 Bag
- Distribution
- Dialysis Centers Direct to patient
- Recall date
- June 12, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)