CAPS Recalls 20 Bags of TPN Neonatal Starter Bag for Sterility Failure
Central Admixture Pharmacy Services is recalling 20 bags of University of Alabama Birmingham TPN Neonatal Starter Bag due to out-of-specification sterility test results.
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 FDA classified this recall as Class I, which corresponds to a Critical severity score of 5 according to the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 20 bags of University of Alabama Birmingham TPN Neonatal Starter Bag. The product is a compounded drug, sterile injectable, IV infusion bag with a compound volume of 100 ml, containing Trophamine 4% Dextrose 10%. The bags were packaged in corrugated boxes lined with polystyrene inserts.
The recall was initiated because the product failed sterility tests for microbial contamination, resulting in out-of-specification results. The specific lot number is 37-74529, with an expiration date of 24 DEC 2014 and a manufacturing date of 15 DEC 2014. The CAPS Rx number is 37-74529-0-20-R and the Disp ID is 37-1124540.
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
- University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, 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
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Affected units
- 20
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 37-74529
- EXP: 24 DEC 2014
- Made on 15 DEC 2014
- CAPS Rx: 37-74529-0-20-R
- Disp ID: 37-1124540
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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