Recalls / Class II
Class IID-927-2013
Product
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, 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: 23-505-EV, Exp. 11/14
Why it was recalled
Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 72,300 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-08-16
- FDA classified
- 2013-08-28
- Posted by FDA
- 2013-09-04
- Terminated
- 2014-10-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-927-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.