Drug product
Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02
D-1588-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 69247
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75,000 vials
- Official record key
drug-enforcement:D-1588-2014
Official wording
Reason: Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.
Code information: LOT 37-268-DK; Exp: 1JAN2016
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter