Why it was recalled
Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).
Product description
ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06.
Lot numbers, UPCs & expiration codes
Lot #: P306225, Exp 08/14
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-1542-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 4, 2014
- FDA report date
- Aug 27, 2014
- Quantity
- 6,204 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp
Original FDA data
Every field from FDA enforcement report D-1542-2014, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 68963
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: P306225, Exp 08/14
- Postal code
- 60015-4625
- Report date
- Aug 27, 2014
- Product type
- Drugs
- Recall number
- D-1542-2014
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corp
- Product quantity
- 6,204 bags
- Termination date
- Jun 10, 2015
- Reason for recall
- Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 4, 2014
- Initial firm notification
- Letter
- Center classification date
- Aug 18, 2014