PHENYLephrine recall: Sterility Concern
PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge…
Why was PHENYLephrine recalled?
Lack of Assurance of Sterility
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?
08-2021-24@6 12/06/2021, 08-2021-31@7 12/12/2021, 09-2021-07@3 12/21/2021, 10-2021-20@2 02/02/2022 & 10-2021-28@2 02/10/2022.
- Product
- PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge…
- Recalling firm
- Edge Pharma, LLC
- Quantity
- 3930 bags
- Distribution
- nationwide
- Recall date
- February 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)