Why it was recalled
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Product description
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04
Lot numbers, UPCs & expiration codes
Product Code 2B7717 Lot # P311357, exp 12/31/2015
Where it was sold
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-0301-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 25, 2014
- FDA report date
- Dec 24, 2014
- Quantity
- 7,220 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-0301-2015, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69868
- Address
- 1 Baxter Pkwy
- Code information
- Product Code 2B7717 Lot # P311357, exp 12/31/2015
- Postal code
- 60015-4625
- Report date
- Dec 24, 2014
- Product type
- Drugs
- Recall number
- D-0301-2015
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 7,220 bags
- Termination date
- Oct 28, 2015
- Reason for recall
- Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 25, 2014
- Initial firm notification
- Letter
- Center classification date
- Dec 16, 2014