D-1161-2014 Class I Terminated
FDA drug recall D-1161-2014 was initiated by Hospira Inc. on Oct 18, 2013 and is designated Class I. Reason for recall: Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored. The recall status is terminated (terminated Dec 18, 2015). Affected quantity: 40,360 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 26, 2014
- Initiation Date
- Oct 18, 2013
- Termination Date
- Dec 18, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,360 vials
Product Description
Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
Reason for Recall
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Distribution Pattern
Nationwide
Code Information
Lot 25-220-DD, Exp 1JAN2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1161-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026