D-1588-2014 Class II Terminated
FDA drug recall D-1588-2014 was initiated by Hospira Inc. on Sep 4, 2014 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Jul 23, 2015). Affected quantity: 75,000 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 24, 2014
- Initiation Date
- Sep 4, 2014
- Termination Date
- Jul 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75,000 vials
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
LOT 37-268-DK; Exp: 1JAN2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1588-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026