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,
Reported: April 30, 2025 Initiated: March 31, 2025 #D-0372-2025
Product Description
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,
Reason for Recall
Lack of Assurance of Sterility: Leaking/damaged syringes.
Details
- Recalling Firm
- Denver Solutions, LLC DBA Leiters Health
- Units Affected
- 7,290 syringes
- Distribution
- Nationwide in the U.S.A
- Location
- Englewood, CO
Frequently Asked Questions
What product was recalled? ▼
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,. Recalled by Denver Solutions, LLC DBA Leiters Health. Units affected: 7,290 syringes.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Leaking/damaged syringes.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 30, 2025. Severity: Moderate. Recall number: D-0372-2025.
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