Pentec Health Recalls Proplete 90+ KG Due to Sterility Concerns
Pentec Health is recalling Proplete 90+ KG dialysate solution because sterility could not be assured. The product was distributed to dialysis centers and directly to patients.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 hazard involves a lack of sterility assurance for a parenteral product, which poses a significant risk of serious injury or infection.
Plain-English summary
Pentec Health Inc. is recalling Proplete 90+ KG, an intraperitoneal parenteral nutrition dialysate solution with added amino acids, in 805mL bags. The recall is due to a lack of assurance of sterility for compounded sterile renal nutritional prescriptions.
The affected product has a compounding date of 04/23/13 and a discard after date of 5/15/13. Distribution was direct to dialysis centers and patients.
Consumers and healthcare providers should stop using the affected product and contact Pentec Health for further instructions.
The recalled product
- Product
- Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
- Manufacturer
- Pentec Health
- Category
- Drug — Parenteral Nutrition
- 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: 04/23/13 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.
See all 15 products in this recall →Related recalls
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