Why it was recalled
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product description
INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lot numbers, UPCs & expiration codes
All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 20-Sep-15, c) 24-Sep-15, d) 20-Sep-15, e) 24-Sep-15, f) 26-Sep-15
Where it was sold
U.S. Including: VA, NC
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-0618-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 18, 2015
- FDA report date
- Feb 3, 2016
- Quantity
- a) 7 Bags, b) 1 Bag, c) 7 Bags, d) 6 Bags e) 7 Bags, f) 7 Bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sentara Enterprises
Original FDA data
Every field from FDA enforcement report D-0618-2016, exactly as published.
Show all FDA fields
- City
- Chesapeake
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 72746
- Address
- 535 Independence Pkwy Ste 300
- Code information
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 20-Sep-15, c) 24-Sep-15, d) 20-Sep-15, e) 24-Sep-15, f) 26-Sep-15
- Postal code
- 23320-5176
- Report date
- Feb 3, 2016
- Product type
- Drugs
- Recall number
- D-0618-2016
- Classification
- Class II
- Recalling firm
- Sentara Enterprises
- Product quantity
- a) 7 Bags, b) 1 Bag, c) 7 Bags, d) 6 Bags e) 7 Bags, f) 7 Bags
- Termination date
- Jun 29, 2016
- Reason for recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Distribution pattern
- U.S. Including: VA, NC
- Recall initiation date
- Sep 18, 2015
- Initial firm notification
- Center classification date
- Jan 28, 2016