Status
Terminated
Drug Enforcement D-0934-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
July 26, 2023
Termination Date
July 8, 2024
Product Information
- Product description
- Norepinephrine 32 mg per 250 mL (128 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 70324-702-01.
- Product quantity
- 2,088 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-0934-2023
- Event ID
- 92657
- Recall initiation date
- July 7, 2023
- Center classification date
- July 19, 2023
- Code info
- Lot #: 490100, Exp 27-Jul-23
- More code info
- —