Drug product
Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32
D-1359-2016
Product summary
- Firm
- Hospira Inc.
- Event
- Event 74399
- Status
- Terminated
- Classification
- Class II
- Quantity
- 373,850 tubes
- Official record key
drug-enforcement:D-1359-2016
Official wording
Reason: Crystallization: Product contains particulate identified to be crystallized active ingredient.
Code information: Lot #: 52610LL, Exp. 01 OCT 2016; Lot #: 57660LL, Exp. 01 MAR 2017
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulate