Status
Terminated
Drug Enforcement D-629-2013
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Classification
Class II
Report Date
July 10, 2013
Termination Date
June 18, 2015
Product Information
- Product description
- Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
- Product quantity
- 172,296 units
- Reason for recall
- Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide & Puerto Rico
Location & Firm
- Recalling firm
- Baxter Healthcare Corp.
- Address
-
1 Baxter Pkwy, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-629-2013
- Event ID
- 65288
- Recall initiation date
- May 21, 2013
- Center classification date
- June 28, 2013
- Code info
- Lot #: P280123, P280123A, Exp 2/14
- More code info
- —