FDA Recall D-0030-2018
Baxter Healthcare Corporation · Deerfield, IL
Class I — life-threatening Terminated 356 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
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.
Recall record
- Recall number
D-0030-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA.
- Recall initiated
- 2017-09-15
- Classified by FDA Center
- 2017-10-24
- FDA published
- 2017-11-01
- Terminated
- 2018-09-06
- Recalling firm
- Baxter Healthcare Corporation
- Firm location
- Deerfield, IL
Drug identification
- Brand name(s)
- INTRALIPID
- Generic name(s)
- I.V. FAT EMULSION
- Manufacturer(s)
- Baxter Healthcare Corporation
- NDC(s)
0338-0519- Route(s)
- INTRAVENOUS