Drug product
Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01
D-012-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 66422
- Status
- Terminated
- Classification
- Class II
- Quantity
- 251,400 vials
- Official record key
drug-enforcement:D-012-2014
Official wording
Reason: Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Code information: Lot #: 28-104-DK*, Exp 10/01/2014 (* lot number may be proceeded with an 01)
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter