Sentara Recalls Intralipid Fat Emulsion Due to Sterility Assurance Issues
Sentara Enterprises is recalling specific lots of Intralipid fat emulsion because the product's sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.
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 recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or in this case, a critical sterility failure for an injectable drug, align with a Severe rating (Score 4) as it poses a serious risk of infection.
Plain-English summary
Sentara Enterprises is recalling specific lots of Intralipid (fat emulsion) packaged in various Homepump sizes (27ml, 125ml, 1800ml, 2000ml, 2350ml, and 2800ml). The recall is being conducted because the company cannot guarantee the sterility of the product.
The affected lots were compounded between September 11, 2015, and September 17, 2015. These prescription-only products were distributed in the United States, specifically in Virginia and North Carolina. The recall involves a total of 35 bags across the different package sizes.
Patients and healthcare providers should stop using the affected Intralipid products and contact Sentara Home Health or their healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Injectable
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 (6)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15
- b) 20-Sep-15
- c) 24-Sep-15
- d) 20-Sep-15
- e) 24-Sep-15
- f) 26-Sep-15
Distribution
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.
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