Proplete 80+ KG recall: Sterility Concern
Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway…
Why was Proplete 80+ KG 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: 04/24/13 Discard after: 5/15/13
- Product
- Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway…
- 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)