D-1278-2014 Class I Terminated
FDA drug recall D-1278-2014 was initiated by Hospira Inc. on Dec 23, 2013 and is designated Class I. Reason for recall: Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution. The recall status is terminated (terminated Oct 7, 2014). Affected quantity: 68,350 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 7, 2014
- Initiation Date
- Dec 23, 2013
- Termination Date
- Oct 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68,350 vials
Product Description
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05.
Reason for Recall
Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
Distribution Pattern
Nationwide
Code Information
Lot 32135DD; Exp 08/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1278-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026