Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

FDA recall notice · announced May 8, 2013 · Hospira

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

The product

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

Reason for recall

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot 17-100-EV and 17-399-EV
Quantity: 172,350 vials
Status: Terminated
Products in this recall event:
- Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12 (D-308-2013)
- Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12 (D-309-2013)

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