FDA Drugs recall ·
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL… recall
- Recall number
- D-0014-2025
- Date
- (initiated September 25, 2024)
- Company / brand
- Fresenius Kabi Compounding, LLC
20 Dan Rd, Canton, MA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 1313 bags
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
CGMP violations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# C274-000039006, exp. date 19-Jan-25
Distribution
Product was distributed to 125 direct accounts nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0014-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.