PHENYLephrine HCl in 0.9% Sodium Chloride recall: Sterility Concern
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
Why was PHENYLephrine HCl in 0.9% Sodium Chloride recalled?
Lack of Assurance of Sterility: Leaking/damaged syringes.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 #: 2431349A, Exp.: 6/16/2025
- Product
- PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Quantity
- 7,290 syringes
- Distribution
- Nationwide in the U.S.A
- Recall date
- April 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)