Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot# C274-000039006, exp. date 19-Jan-25
Where it was sold
Product was distributed to 125 direct accounts nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0014-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 25, 2024
- FDA report date
- Oct 30, 2024
- Quantity
- 1313 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi Compounding, LLC
Original FDA data
Every field from FDA enforcement report D-0014-2025, exactly as published.
Show all FDA fields
- City
- Canton
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 95427
- Address
- 20 Dan Rd
- Code information
- Lot# C274-000039006, exp. date 19-Jan-25
- Postal code
- 02021-2809
- Report date
- Oct 30, 2024
- Product type
- Drugs
- Recall number
- D-0014-2025
- Classification
- Class II
- Recalling firm
- Fresenius Kabi Compounding, LLC
- Product quantity
- 1313 bags
- Termination date
- Aug 15, 2025
- Reason for recall
- CGMP violations
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- Sep 25, 2024
- Initial firm notification
- Letter
- Center classification date
- Oct 21, 2024