Status
Terminated
Drug Enforcement D-0930-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
July 26, 2023
Termination Date
July 8, 2024
Product Information
- Product description
- Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
- Product quantity
- 137,304 bags
- 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
- SterRx, LLC
- Address
-
141 Idaho Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0930-2023
- Event ID
- 92657
- Recall initiation date
- July 7, 2023
- Center classification date
- July 19, 2023
- Code info
- Lot #: 489344, Exp 25-Jul-23; 489352, Exp 26-Jul-23; 489361, Exp 27-Jul-23; 489387, 491647, Exp 28-Jul-23; 492181, Exp 29-Jul-23; 492199, 492201, Exp 2-Aug-23; 492210, 492228, Exp 3-Aug-23; 492236, 492244, Exp 4-Aug-23; 492261, Exp 5-Aug-23; 492279, 492287, Exp 8-Aug-23; 492295, 492308, Exp 9-Aug-23; 492957, 492965, Exp 19-Sep-23; 492973, 492981, Exp 20-Sep-23; 494194, 494207, Exp 21-Sep-23;494215, 494223, Exp 22-Sep-23; 494231, 495200, Exp 23-Sep-23; 495218, 495453, Exp 26-Sep-23; 495470, 495488, Exp 27-Sep-23; 495496, 495509, Exp 28-Sep-23; 495517, 495525, Exp 29-Sep-23; 495533, Exp 30-Sep-23; 495699, 495701, Exp 3-Oct-23; 495710, 495728, Exp 4-Oct-23; 496106, 497491, Exp 15-Nov-23; 497504, 497512, Exp 16-Nov-23; 497521, 497539, Exp 22-Nov-23; 497547, 497555, Exp 23-Nov-23; 497563, Exp 24-Nov-23; 497571, Exp 29-Nov-23; 497598, Exp 30-Nov-23; 497619, 498363, Exp 1-Dec-23; 498371, 498380, 498398, Exp 5-Dec-23; 498401, Exp 6-Dec-23; 498419, 498427, Exp 7-Dec-23; 498435, Exp 8-Dec-23; 498443, 498451, Exp 12-Dec-23; 498460, Exp 13-Dec-23; 498478, Exp 14-Dec-23; 498507, Exp 24-Jan-24; 498515, 498523, Exp 25-Jan-24; 498531, 498540, Exp 26-Jan-24; 498558, Exp 27-Jan-24; 498574, Exp 30-Jan-24; 498582, 499665, Exp 31-Jan-24; 500355, 500363, Exp 1-Feb-24; 500371, 500380, Exp 2-Feb-24; 500398, 500401, Exp 3-Feb-24; 500419, 500427, Exp 6-Feb-24; 500435, 500443, Exp 7-Feb-24; 500451, 500460, Exp 8-Feb-24; 500478, Exp 9-Feb-24
- More code info
- —