Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
Reported: March 15, 2023 Initiated: February 21, 2023 #D-0445-2023
Product Description
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
Reason for Recall
CGMP DEVIATIONS
Details
- Recalling Firm
- Denver Solutions, LLC DBA Leiters Health
- Units Affected
- 8,136 units
- Distribution
- Nationwide within the United States including VA or other Government facilities
- Location
- Englewood, CO
Frequently Asked Questions
What product was recalled? ▼
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94. Recalled by Denver Solutions, LLC DBA Leiters Health. Units affected: 8,136 units.
Why was this product recalled? ▼
CGMP DEVIATIONS
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 15, 2023. Severity: Moderate. Recall number: D-0445-2023.
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