Status
Terminated
Drug Enforcement D-0932-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
July 26, 2023
Termination Date
July 8, 2024
Product Information
- Product description
- Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.
- Product quantity
- 125,598 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-0932-2023
- Event ID
- 92657
- Recall initiation date
- July 7, 2023
- Center classification date
- July 19, 2023
- Code info
- Lot #: 490071, Exp 30-Jul-23; 490089, Exp 4-Aug-23; 490118, 490126, Exp 5-Aug-23; 490169, Exp 10-Aug-23; 491276, Exp 11-Aug-23; 491284, Exp 12-Aug-23; 491612, Exp 18-Aug-23; 497467, Exp 8-Dec-23; 497475, Exp 9-Dec-23; 499104, Exp 18-Jan-24; 499112, Exp 19-Jan-24; 499121, 499278, Exp 20-Jan-24; 499358, Exp 21-Jan-24; 502019, Exp 24-Mar-24; 502027, Exp 29-Mar-24; 502035, Exp 5-Apr-24; 503513, Exp 18-Apr-24; 504217, Exp 20-Apr-24
- More code info
- —