Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino a...

FDA Drug Recall #D-592-2013 — Class II — May 15, 2013

Recall Summary

Recall Number D-592-2013
Classification Class II — Moderate risk
Date Initiated May 15, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Pentec Health
Location Boothwyn, PA
Product Type Drugs
Quantity 4 Bags

Product Description

Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

Reason for Recall

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Distribution Pattern

Dialysis Centers Direct to patient

Lot / Code Information

Compounding Date: 04/24/13 Discard after: 5/15/13

Other Recalls from Pentec Health

Recall # Classification Product Date
D-585-2013 Class II IDPN (Intradialytic Parenteral Nutrition - dial... May 15, 2013
D-595-2013 Class II Baxter LL bag 2% Amino Acids (Intraperitoneal P... May 15, 2013
D-589-2013 Class II Proplete 70+ KG (Intraperitoneal Parenteral Nut... May 15, 2013
D-587-2013 Class II Proplete 52 - 59 KG (Intradialytic Parenteral N... May 15, 2013
D-591-2013 Class II Proplete 90+ KG (Intraperitoneal Parenteral Nut... May 15, 2013

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.