D-1450-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 3, 2016
- Initiation Date
- June 13, 2016
- Termination Date
- September 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3990 vials
Product Description
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
Reason for Recall
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Distribution Pattern
Nationwide
Code Information
Lot #: OXT515, Exp. July 2017