Why it was recalled
Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
Product description
10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06
Lot numbers, UPCs & expiration codes
Lot #: P333617, Exp 4/30/17
Where it was sold
US
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-0425-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 6, 2016
- FDA report date
- Jan 18, 2017
- Quantity
- 3,528 eaches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0425-2017, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 75835
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: P333617, Exp 4/30/17
- Postal code
- 60015-4625
- Report date
- Jan 18, 2017
- Product type
- Drugs
- Recall number
- D-0425-2017
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 3,528 eaches
- Termination date
- Mar 26, 2018
- Reason for recall
- Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06
- Distribution pattern
- US
- Recall initiation date
- Dec 6, 2016
- Center classification date
- Jan 9, 2017