Recalls / Class II
Class IID-1450-2016
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
- Affected lot / code info
- Lot #: OXT515, Exp. July 2017
Why it was recalled
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Recalling firm
- Firm
- Sagent Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1901 N Roselle Rd Ste 700, N/A, Schaumburg, Illinois 60195-3194
Distribution
- Quantity
- 3990 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-06-13
- FDA classified
- 2016-07-28
- Posted by FDA
- 2016-08-03
- Terminated
- 2017-09-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1450-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.