Recalls / Class II
Class IID-0016-2025
Product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
- Affected lot / code info
- Lot #C274-000037039, exp. date 9-Oct-24 C274-000037239, exp. date 21-Oct-24
Why it was recalled
cGMP violations
Recalling firm
- Firm
- Fresenius Kabi Compounding, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Dan Rd, N/A, Canton, Massachusetts 02021-2809
Distribution
- Quantity
- 2756 bags
- Distribution pattern
- Product was distributed to 125 direct accounts nationwide.
Timeline
- Recall initiated
- 2024-09-25
- FDA classified
- 2024-10-21
- Posted by FDA
- 2024-10-30
- Terminated
- 2025-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0016-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.