Recalls / Class I
Class ID-0280-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.
- Affected lot / code info
- Lot #: 2330939, Exp. Date 01/30/2024; 2331032, Exp. Date 02/03/2024; 2331112, Exp. Date 03/19/2024; 2331190, Exp. Date 03/26/2024; 2331429, Exp. Date 04/28/2024.
Why it was recalled
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Recalling firm
- Firm
- Denver Solutions, LLC DBA Leiters Health
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 13796 Compark Blvd, Englewood, Colorado 80112-7145
Distribution
- Quantity
- 12,564 IV bags
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-12-28
- FDA classified
- 2024-01-29
- Posted by FDA
- 2024-02-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0280-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.