Drug product
6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55
D-1271-2014
Product summary
- Event
- Event 66913
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4614 units
- Official record key
drug-enforcement:D-1271-2014
Official wording
Reason: Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Code information: Lot# J2H002, Exp 06/14; J2S018, Exp 12/14
Distribution pattern: Nationwide, Puerto Rico and Spain
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter