FDA Recalls Non-Sterile Neonatal TPN Bags Due to Microbial Contamination
Central Admixture Pharmacy Services is recalling 10 bags of neonatal TPN due to failed sterility tests 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 recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death, meeting the criteria for a Critical severity score.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 10 bags of Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag. The product is a compounded sterile injectable IV infusion bag containing Trophamine 10%/3% Dextrose 70%/10% and Calcium Gluconate. The recall was initiated because the product failed sterility tests for microbial contamination, resulting in out-of-specification results.
The affected product is identified by lot number 37-74779, with a manufacture date of 15 DEC 2014 and an expiration date of 24 DEC 2014. The bags were distributed nationwide. Each container is packaged in a corrugated box lined with a polystyrene insert.
Healthcare providers and patients should stop using the affected product immediately. Consumers should contact their healthcare provider for further instructions regarding the disposal or replacement of the recalled medication.
The recalled product
- Product
- Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with…
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Affected units
- 10
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 37-74779
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74779-0-10-R
- Disp ID: 37-1124608
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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