Central Admixture Pharmacy Services Recalls Compounded TPN Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling three bags of compounded TPN due to out-of-specification sterility test results indicating microbial contamination.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which corresponds to a Critical severity score per the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling three bags of compounded Total Parenteral Nutrition (TPN) products. The specific product is Methodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dextrose 5%, with additives including heparin and calcium gluconate. The bags are sterile injectable, prescription-only, compounded drugs packaged in corrugated boxes with polystyrene inserts.
The recall was initiated because the product failed sterility tests for microbial contamination, resulting in out-of-specification results. This indicates a potential lack of sterility in the injectable solution.
The affected lot number is 37-74767, with a manufacture date of December 15, 2014, and an expiration date of December 24, 2014. The distribution pattern is listed as nationwide. Consumers and healthcare providers should discontinue use of the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Affected units
- 3
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 (5)
- lot number 37-74767
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74767-0-3-R
- Disp ID: 37-1124457
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by Central Admixture Pharmacy Services, Inc. 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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