D-0030-2018 Class I Terminated
FDA drug recall D-0030-2018 was initiated by Baxter Healthcare Corporation on Sep 15, 2017 and is designated Class I. 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… The recall status is terminated (terminated Sep 6, 2018). Affected quantity: 910 bags.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 1, 2017
- Initiation Date
- Sep 15, 2017
- Termination Date
- Sep 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 910 bags
Product description
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.
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.
Code information
Lot #: 10LE9597, Exp 04/01/19
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0030-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026