Class II · Moderate risk
Intralipid
cGMP deviations: Temperature abuse
National Drug Code
Is NDC 0338-0519-09 recalled?
Intralipid · 250 mL in 1 BAG (0338-0519-09)
Yes — this exact package was recalled
1 FDA recall names the code 0338-0519-09 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- I.V. Fat Emulsion
- Strength
- SOYBEAN OIL 20 g/100mL
- Form
- Emulsion · Intravenous
- Labeler
- Baxter Healthcare Corporation
- Type
- Human Prescription Drug
- Product code
- 0338-0519
Recalls naming this package
Class II · Moderate risk
Intralipid
cGMP deviations: Temperature abuse
Class I · High risk
Intralipid 20%
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
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