Fresenius Kabi Compounding, LLC: Drug Recall
Recall #D-0014-2025 · 09/25/2024
Class II: Risk
Recall Details
- Recall Number
- D-0014-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Fresenius Kabi Compounding, LLC
- Status
- Terminated
- Date Initiated
- 09/25/2024
- Location
- Canton, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1313 bags
Reason for Recall
CGMP violations
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
Distribution Pattern
Product was distributed to 125 direct accounts nationwide.
Other Recalls by Fresenius Kabi Compounding, LLC
- Class II: Risk 09/25/2024
- Class II: Risk 09/25/2024
- Class II: Risk 09/25/2024
- Class II: Risk 09/25/2024
- Class II: Risk 09/25/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.