Status
Completed
Drug Enforcement D-0141-2024
Lack of assurance of sterility.
Classification
Class II
Report Date
December 13, 2023
Termination Date
—
Product Information
- Product description
- ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10
- Product quantity
- 825 syringes
- Reason for recall
- Lack of assurance of sterility.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Philadelphia, Pennsylvania.
Location & Firm
- Recalling firm
- Wells Pharma of Houston LLC
- Address
-
9265 Kirby Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0141-2024
- Event ID
- 93496
- Recall initiation date
- November 22, 2023
- Center classification date
- December 6, 2023
- Code info
- Lot # 11092313110#01, Exp 01/12/24
- More code info
- —