Drug product
0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31
D-1265-2014
Product summary
- Event
- Event 66913
- Status
- Terminated
- Classification
- Class I
- Quantity
- 53,592 units
- Official record key
drug-enforcement:D-1265-2014
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# J2P912, Exp 02/14
Distribution pattern: Nationwide, Puerto Rico and Spain
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter