Recall Z-1528-2010 ยท CGN Acid, Folic, Radioimmunoassay
Baxter Healthcare Corp.
Baxter RenAmin (Amino Acid) Injection; Pharmacy Bulk Package Not for Direct Infusion, Rx Only, 250 mL type II glass bottles; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, Made in USA; product code 2A6222.
| Date | Apr 29, 2010 (initiated Feb 15, 2010) |
| Status | Terminated |
| Reason | Routine stability testing of the evacuated container product, along with trending of results, indicates that the pH will exceed the upper specification limit prior to the expiration date of this product. Baxter decided to remove all potentially affected products even though there have been no out-of-specification pH results at the 0, 6 and 12 month intervals. The recall was initiated on 2/15/10. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Product Recall letters dated 2/15/10 were mailed on the same date via first class mail to the affected direct accounts to the attention of the Director of Pharmacy, the Director of Materials Management, and the Director of Risk Management. The accounts were informed of the potential for the pH of the products to exceed the upper specification limits for pH prior to the product expiration date. The accounts were requested discontinue use and segregate the affected lots of products from inventory and call Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7:00 |
| Quantity | 4,164 units |
| Distribution | United States -- Nationwide and Puerto Rico, Canada and Saudi Arabia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.