Status
Ongoing
Drug Enforcement D-0936-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
August 2, 2023
Termination Date
—
Product Information
- Product description
- Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
- Product quantity
- 65,710 vials for 1 g and 2 g strength
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Sagent Pharmaceuticals
- Address
-
1901 N Roselle Rd Ste 450, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0936-2023
- Event ID
- 92678
- Recall initiation date
- July 11, 2023
- Center classification date
- July 21, 2023
- Code info
- Lot #: a) OXL202, exp 6/30/2025; OXL204, exp 6/30/2025; OXL301, exp 12/31/2025; OXL205, exp 11/30/2025; b) OXL201, exp 5/31/2025; OXL203, exp 6/30/2025
- More code info
- —