Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82

FDA recall notice · announced March 15, 2023 · Denver Solutions, Llc Dba Leiters Health

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82

Reason for recall

CGMP DEVIATIONS

Notes

Distribution: Nationwide within the United States including VA or other Government facilities
Lot/code information: Lot #: 2231017, Exp. Date 3/12/2023
Quantity: 1212 units
Status: Terminated
Products in this recall event:
- Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11 (D-0442-2023)
- Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15 (D-0443-2023)
- 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 (D-0445-2023)
- Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82 (D-0444-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.