PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride recall: Sterility Concern
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals…
Why was PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride 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?
Lot #: 1223045974 Exp 12/18/23; 1223046535 Exp 01/11/24; 1223049152 Exp 05/02/24 Expanded Lot #: 1223048067, Exp 04/06/2024; 1223048792, Exp 04/17/2024.
- Product
- PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals…
- Recalling firm
- SCA Pharmaceuticals, LLC
- Quantity
- 3,671 syringes, expanded 1,911 syringes
- Distribution
- Nationwide in the USA
- Recall date
- April 3, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)