Recalls / Class I
Class ID-0030-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0519-58
- Brand name
- Intralipid
- Generic name
- I.v. Fat Emulsion
- Active ingredient
- Soybean Oil
- Route
- Intravenous
- NDC
- 0338-0519
- FDA application
- NDA018449
- Affected lot / code info
- Lot #: 10LE9597, Exp 04/01/19
Why it was recalled
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.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 910 bags
- Distribution pattern
- Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2017-09-15
- FDA classified
- 2017-10-24
- Posted by FDA
- 2017-11-01
- Terminated
- 2018-09-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0030-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.