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.
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
Lot numbers, UPCs & expiration codes
Lot #: 10LE9597, Exp 04/01/19
Where it was sold
Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0030-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 15, 2017
- FDA report date
- Nov 1, 2017
- Quantity
- 910 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0030-2018, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 78155
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: 10LE9597, Exp 04/01/19
- Postal code
- 60015-4625
- Report date
- Nov 1, 2017
- Product type
- Drugs
- Recall number
- D-0030-2018
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 910 bags
- Termination date
- Sep 6, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- 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.
- Recall initiation date
- Sep 15, 2017
- Initial firm notification
- Letter
- Center classification date
- Oct 24, 2017