D-0002-2015 Class I Terminated
FDA drug recall D-0002-2015 was initiated by Hospira Inc. on Jun 17, 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 Apr 3, 2017). Affected quantity: 40,730 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 8, 2014
- Initiation Date
- Jun 17, 2014
- Termination Date
- Apr 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,730 vials
Product Description
Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29
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 # 33-545-DD, Exp. 09/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0002-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026