Status
Terminated
Drug Enforcement D-1378-2012
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
Classification
Class II
Report Date
June 20, 2012
Termination Date
June 28, 2018
Product Information
- Product description
- CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.
- Product quantity
- 30 mL: 2,078,800 vials; 100 mL: 167,100 vials
- Reason for recall
- Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide, Puerto Rico, and Abu Dhabi
Location & Firm
- Recalling firm
- Luitpold Pharmaceuticals, Inc.
- Address
-
One Luitpold Drive, P.O. Box 9001
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1378-2012
- Event ID
- 58410
- Recall initiation date
- March 15, 2011
- Center classification date
- June 14, 2012
- Code info
- 30 mL Lots: 9198, 9252, 9299, 9305, 9402, 9423, 9432, 9553, 9595, 9646, 9681, 9737, 9797, 9831, 0051, 0095, 0362; 100 mL Lots: 9225, 9492, 9711, 0007, 0058
- More code info
- —