D-1358-2014 Class I Terminated
FDA drug recall D-1358-2014 was initiated by Hospira Inc. on Apr 21, 2014 and is designated Class I. Reason for recall: Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution. The recall status is terminated (terminated Mar 16, 2017). Affected quantity: 85,680 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 11, 2014
- Initiation Date
- Apr 21, 2014
- Termination Date
- Mar 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85,680 vials
Product Description
Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.
Reason for Recall
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Distribution Pattern
Nationwide.
Code Information
Lot #: 34-440-DD, Exp 10/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1358-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026