Pentec Health Recalls Proplete 80+ KG Due to Sterility Concerns
Pentec Health is recalling Proplete 80+ KG renal nutritional prescriptions because sterility could not be assured for the compounded sterile products.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in sterile products) fall under the Severe category.
Plain-English summary
Pentec Health Inc. is recalling Proplete 80+ KG, an intraperitoneal parenteral nutrition dialysate solution with added amino acids, in 710mL bags. The recall is due to a lack of assurance of sterility for compounded sterile renal nutritional prescriptions.
The affected products were distributed to dialysis centers and directly to patients. The specific compounding date for the recalled units is 04/24/13, with a discard after date of 5/15/13.
Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
- Manufacturer
- Pentec Health
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Compounding Date: 04/24/13 Discard after: 5/15/13
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Pentec Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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