The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0614-2016·Announced 2016-02-03

Sentara Parenteral Amino Acid Infusion Recalled for Sterility Concerns

Sentara Enterprises is recalling Parenteral Amino Acid Infusion 10% bags because product sterility cannot be guaranteed. The recall affects specific lots compounded in September 2015.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are typically scored as Severe (4), especially for sterile medical products where sterility assurance is compromised, even without reported hospitalizations in the text.

Plain-English summary

Sentara Enterprises is recalling Parenteral Amino Acid Infusion 10% packaged in various Homepump sizes. The recall is due to a lack of assurance of sterility, meaning the product sterility cannot be guaranteed. The affected product is prescription-only and was distributed in Virginia and North Carolina.

The recall covers all lots compounded between September 11, 2015, and September 17, 2015. Specific quantities and expiration dates vary by bag size, ranging from 780ml to 3500ml. The source text does not report any specific illnesses or injuries associated with this recall.

Patients and healthcare providers should stop using the affected product and contact their healthcare provider for instructions on replacement or further care. Consumers should verify lot numbers and expiration dates against the recall details provided by the manufacturer.

The recalled product

Product
Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps…
Manufacturer
Sentara Enterprises
Category
Drug — Parenteral Nutrition
Hazard

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 (18)

  • All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 26-Sep-15
  • b) 16-Sep-15 c) 25-Sep-15
  • d) 25-Sep-15 e) 20-Sep-15
  • 26-Sep-15
  • f) 20-Sep-15
  • 24-Sep-15
  • g) 20-Sep-15
  • h) 20-Sep-15
  • i) 15-Sep-15
  • j) 26-Sep-15
  • k) 25-Sep-15
  • l) 20-Sep-15
  • 23-Sep-15
  • m) 20-Sept-15
  • n) 23-Sep-15
  • o) 20-Sep-15
  • p) 26-Sep-15
  • q) 20-Sep-15

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 34 recalled by Sentara Enterprises 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.

See all 34 products in this recall →

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