FDA Recall D-0937-2023
Sagent Pharmaceuticals · Schaumburg, IL
Class II Ongoing 1038 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Reason for recall
Lack of Assurance of Sterility
Recall record
- Recall number
D-0937-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2023-07-11
- Classified by FDA Center
- 2023-07-21
- FDA published
- 2023-08-02
- Recalling firm
- Sagent Pharmaceuticals
- Firm location
- Schaumburg, IL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.