PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% recall: Sterility Concern
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor…
Why was PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% recalled?
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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 # 1220023003, BUD 12/22/2020; 1220023057, BUD 12/25/2020; 1220023104, BUD 12/25/2020; 1220023144, BUD 12/27/2020; 1220023168, BUD 12/27/2020; 1220023222, BUD 12/29/2020; 1220023240, BUD 12/28/2020; 1220023284, BUD 1/1/2021; 1220023456, BUD 1/8/2021; 1220023474, BUD 1/4/2021; 1220023530, BUD 1/8/2021 & 1220023542, BUD 1/9/2021.
- Product
- PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor…
- Recalling firm
- SCA Pharmaceuticals
- Quantity
- 3152 syringes
- Distribution
- Product was distributed to hospitals nationwide.
- Recall date
- January 13, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)