D-0388-2015 Class II Terminated
FDA drug recall D-0388-2015 was initiated by Hospira Inc. on Oct 6, 2014 and is designated Class II. Reason for recall: Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. The recall status is terminated (terminated Dec 15, 2016). Affected quantity: 100 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 25, 2015
- Initiation Date
- Oct 6, 2014
- Termination Date
- Dec 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 vials
Product Description
Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01.
Reason for Recall
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Distribution Pattern
Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.
Code Information
One shipment of Lot #: 34-540-DK; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0388-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026