Recalls / Class I
Class ID-0277-2024
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
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.
- Affected lot / code info
- Lot #: 2331062, Exp. Date: 02/08/2024; 2331224, Exp. Date 03/18/2024; 2331270, Exp. Date 03/28/2024.
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
- 8,976 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-0277-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.