CAPS Recalls Lankenau Hospital TPN Neonatal Starter Bags for Sterility Failure
Central Admixture Pharmacy Services is recalling six Lankenau Hospital TPN Neonatal Starter Bags due to out-of-specification sterility test results.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling six units of Lankenau Hospital (PA) TPN Neonatal Starter Bag. The product is a compounded drug containing Trophamine 2.5%, Dextrose 10%, heparin PF 62.5 units, and Calcium Gluconate 500mg in a 250 ml sterile injectable IV infusion bag. The specific lot number is 37-74671, with a manufacture date of December 15, 2014, and an expiration date of December 24, 2014.
The recall was initiated because the product failed sterility tests for microbial contamination, resulting in out-of-specification results. This indicates a potential risk of non-sterility in the affected bags.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and discontinue use if found. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- Lankenau Hospital (PA) TPN Neonatal Starter Bag, Trophamine 2.5%, Dextrose 10%, Additives: heparin PF 62.5 units, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined wit
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Affected units
- 6
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 37-74671
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74671-0-6-R
- Disp ID: 37-1124546
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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