openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 4
Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Code information
One shipment of Lot #: 34-366-8E02; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI
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.
drug · product 2 of 4
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.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Code information
One shipment of Lot #: 34-540-DK; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI
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.
drug · product 3 of 4
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Code information
One shipment of Lot #: 33-750-DJ; Exp 1SEP2015 to The Harvard Drug Group, Livonia, MI
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.
drug · product 4 of 4
Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Code information
Lot #: 35-315-DD; Exp 1NOV2015
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.
