Recalls / Class II
Class IID-1359-2016
Product
Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32
- Brand name
- Diazepam
- Generic name
- Diazepam
- Active ingredient
- Diazepam
- Route
- Intramuscular, Intravenous
- NDC
- 0409-1273
- FDA application
- ANDA072079
- Affected lot / code info
- Lot #: 52610LL, Exp. 01 OCT 2016; Lot #: 57660LL, Exp. 01 MAR 2017
Why it was recalled
Crystallization: Product contains particulate identified to be crystallized active ingredient.
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
- 373,850 tubes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-06-23
- FDA classified
- 2016-07-12
- Posted by FDA
- 2016-07-20
- Terminated
- 2018-08-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1359-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.