PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride recall: Sterility Concern
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA…
Why was PHENYLephrine HCl 400 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 #: 1223045040 Exp 11/13/23, 1223046397 Exp 01/06/24, 1223046505 Exp 01/10/24, 1223047254 Exp 02/08/24, 1223047436 Exp 02/15/24, 1223047938 Exp 03/13/24, 1223049150 Exp 05/02/24, 1223049300 Exp 05/09/24, Expanded Lot #: 1223048569, Exp 04/06/2024; 1223049600, Exp 05/19/2024
- Product
- PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA…
- Recalling firm
- SCA Pharmaceuticals, LLC
- Quantity
- 10,017 syringes, expanded 2579 syringes
- Distribution
- Nationwide in the USA
- Recall date
- April 3, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)