Why it was recalled
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Product description
Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04.
Lot numbers, UPCs & expiration codes
Lot#: P287045, Exp 6/2014
Where it was sold
US Nationwide
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-1158-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 18, 2013
- FDA report date
- Mar 26, 2014
- Quantity
- 14,574 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-1158-2014, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 67107
- Address
- 1 Baxter Pkwy
- Code information
- Lot#: P287045, Exp 6/2014
- Postal code
- 60015-4625
- Report date
- Mar 26, 2014
- Product type
- Drugs
- Recall number
- D-1158-2014
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 14,574 bags
- Termination date
- Sep 20, 2016
- Reason for recall
- Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04.
- Distribution pattern
- US Nationwide
- Recall initiation date
- Nov 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Mar 14, 2014