Why it was recalled
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product description
Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Lot numbers, UPCs & expiration codes
Compounding Date: 04/24/13 Discard after: 05/15/13
Where it was sold
Dialysis Centers Direct to patient
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-586-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 15, 2013
- FDA report date
- Jun 12, 2013
- Quantity
- 9 Bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pentec Health
Original FDA data
Every field from FDA enforcement report D-586-2013, exactly as published.
Show all FDA fields
- City
- Boothwyn
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 65180
- Address
- 4 Creek Pkwy Ste A
- Code information
- Compounding Date: 04/24/13 Discard after: 05/15/13
- Postal code
- 19061-3132
- Report date
- Jun 12, 2013
- Product type
- Drugs
- Recall number
- D-586-2013
- Classification
- Class II
- Recalling firm
- Pentec Health
- Product quantity
- 9 Bags
- Termination date
- Dec 16, 2014
- Reason for recall
- Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
- Distribution pattern
- Dialysis Centers Direct to patient
- Recall initiation date
- May 15, 2013
- Initial firm notification
- Telephone
- Center classification date
- Jun 6, 2013