Drug product
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.
D-1216-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 71377
- Status
- Terminated
- Classification
- Class I
- Quantity
- 150,950 Vials
- Official record key
drug-enforcement:D-1216-2015
Official wording
Reason: Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Code information: Lot #: 38-515-DK, Expiry: 1 FEB 2016.
Distribution pattern: U.S. Nationwide including Guam.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter