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
Reported: October 30, 2024 Initiated: September 25, 2024 #D-0014-2025
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
Reason for Recall
CGMP violations
Details
- Recalling Firm
- Fresenius Kabi Compounding, LLC
- Units Affected
- 1313 bags
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Location
- Canton, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Kabi Compounding, LLC. Units affected: 1313 bags.
Why was this product recalled? ▼
CGMP violations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 30, 2024. Severity: Moderate. Recall number: D-0014-2025.
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