Drug product
Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311
D-1275-2014
Product summary
- Event
- Event 66913
- Status
- Terminated
- Classification
- Class I
- Quantity
- 5,592 units
- Official record key
drug-enforcement:D-1275-2014
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# J3B007, Exp 08/14
Distribution pattern: Nationwide, Puerto Rico and Spain
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter