Drug product
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
D-0112-2018
Product summary
- Event
- Event 78767
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,576 containers
- Official record key
drug-enforcement:D-0112-2018
Official wording
Reason: Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Code information: Lot #: J7N965, Exp. 10/31/2020
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter