Status
Terminated
Drug Enforcement D-0014-2025
CGMP violations
Classification
Class II
Report Date
October 30, 2024
Termination Date
August 15, 2025
Product Information
- Product description
- Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
- Product quantity
- 1313 bags
- Reason for recall
- CGMP violations
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to 125 direct accounts nationwide.
Location & Firm
- Recalling firm
- Fresenius Kabi Compounding, LLC
- Address
-
20 Dan Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0014-2025
- Event ID
- 95427
- Recall initiation date
- September 25, 2024
- Center classification date
- October 21, 2024
- Code info
- Lot# C274-000039006, exp. date 19-Jan-25
- More code info
- —