Why it was recalled
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Product description
KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20.
Lot numbers, UPCs & expiration codes
1) Lot # 10HH8781, Expiry: 07-2016; 2) Lot # 10HH8739, Expiry: 07-2016.
Where it was sold
US; Nationwide, including Puerto Rico
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-1114-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 28, 2015
- FDA report date
- Jun 10, 2015
- Quantity
- 5,488 Bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-1114-2015, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71222
- Address
- 3 Corporate Dr
- Code information
- 1) Lot # 10HH8781, Expiry: 07-2016; 2) Lot # 10HH8739, Expiry: 07-2016.
- Postal code
- 60047-8930
- Report date
- Jun 10, 2015
- Product type
- Drugs
- Recall number
- D-1114-2015
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 5,488 Bags
- Termination date
- May 19, 2016
- Reason for recall
- Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20.
- Distribution pattern
- US; Nationwide, including Puerto Rico
- Recall initiation date
- Apr 28, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 3, 2015