Status
Terminated
Drug Enforcement D-0933-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
July 26, 2023
Termination Date
July 8, 2024
Product Information
- Product description
- Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.
- Product quantity
- 92,148 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-0933-2023
- Event ID
- 92657
- Recall initiation date
- July 7, 2023
- Center classification date
- July 19, 2023
- Code info
- Lot #: 490097, Exp 3-Aug-23; 490142, Exp 10-Aug-23; 491292, Exp 13-Aug-23; 494442, Exp 26-Nov-23; 496763, Exp 30-Nov-23; 496771, Exp 1-Dec-23; 497408, Exp 2-Dec-23; 497416, Exp 3-Dec-23; 499438, Exp 28-Jan-24; 501032, Exp 8-Feb-24; 501059, Exp 15-Feb-24; 502043, Exp 28-Mar-24; 502051, Exp 31-Mar-24; 503505, Exp 4-Apr-24; 504031, Exp 7-Apr-24; 504250, Exp 19-Apr-24
- More code info
- —