D-887-2013 Class II Terminated
FDA drug recall D-887-2013 was initiated by Hospira Inc. on May 25, 2013 and is designated Class II. Reason for recall: Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel The recall status is terminated (terminated Sep 18, 2014). Affected quantity: 94,110 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 21, 2013
- Initiation Date
- May 25, 2013
- Termination Date
- Sep 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 94,110 vials
Product Description
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33
Reason for Recall
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
Distribution Pattern
Nationwide
Code Information
Lot 07-950-DJ Exp. Date 1JUL2013, 10-101-DJ Exp. Date 1OCT2013, and 10-102-DJ Exp. Date 1OCT2013
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-887-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026