Recalls / Class II
Class IID-0710-2022
Product
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-494-15
- Affected lot / code info
- Lot #: F2101652, F2101653, Exp 5/30/22; F2200111, Exp 7/27/22
Why it was recalled
Defective container
Recalling firm
- Firm
- Athenex Pharma Solutions, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11342 Main St, N/A, Clarence, New York 14031-1718
Distribution
- Quantity
- 1,800 bags
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2022-03-14
- FDA classified
- 2022-03-21
- Posted by FDA
- 2022-03-30
- Terminated
- 2022-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0710-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.