Drug product
Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69
D-1450-2016
Product summary
- Event
- Event 74373
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3990 vials
- Official record key
drug-enforcement:D-1450-2016
Official wording
Reason: Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Code information: Lot #: OXT515, Exp. July 2017
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter