Recalls / Class II
Class IID-313-2013
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
- Brand name
- Diazepam
- Generic name
- Diazepam
- Active ingredient
- Diazepam
- Route
- Intramuscular, Intravenous
- NDC
- 0409-3213
- FDA application
- ANDA071583
- Affected lot / code info
- Lot 05-585-EV Exp. 05/13
Why it was recalled
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 114,000 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-02-26
- FDA classified
- 2013-05-06
- Posted by FDA
- 2013-05-15
- Terminated
- 2014-11-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-313-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.