Class I · High risk
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection)
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Methodist Hospital Northlake
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Methodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dextrose 5%, Additives: heparin PF 100 units/mL, 50 units/dL, Calcium Gluconate 0.46 mEq/mL, 200 mg/dL, compound vol: 300 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Drug: Heparin
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-447-2015 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Heparin recalls
See all
Class II · Moderate risk
heparin added to 0.9% sodium chloride
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Other recalls by Central Admixture Pharmacy Services, Inc.
All 2014 recalls
Class III · Low risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect Product Formulation
Class II · Moderate risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect product formulation: bag did not contain copper and famotidine per label.
Class I · High risk
PHENYLephrine added to 0.9% sodium chloride
Presence of Particulate Matter
Class II · Moderate risk
HYDROmorphone in dextrose 5%
Lack of assurance of sterility:
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