Phenylephrine HCl 0.9% Sodium Chloride Injection USP recall: CGMP Deviations
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 Phenylephrine HCl 0.9% Sodium Chloride Injection USP recalled?
CGMP violations
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# C274-000039006, exp. date 19-Jan-25
- 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
- Recalling firm
- Fresenius Kabi Compounding, LLC
- Quantity
- 1313 bags
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Recall date
- October 30, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)