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 7
Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-256-09
Labeling or packagingreason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Code information
Lot: 170340164s Lot: 170380152s Ex.: 01/1/1900
Distribution pattern
Nationwide
drug · product 2 of 7
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-03
Labeling or packagingreason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Code information
Lot: 170340167s; Exp. 01/01/1900
Distribution pattern
Nationwide
drug · product 3 of 7
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-25
Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 600 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-279-33
Labeling or packagingreason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Code information
Lot: 170170204s; Exp. 01/01/1900
Distribution pattern
Nationwide
drug · product 5 of 7
Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chloride Injection, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-100-13
Labeling or packagingreason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Code information
Lot: 170310113s; Exp. 01/01/1900
Distribution pattern
Nationwide
drug · product 6 of 7
Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 270 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-044-57
Labeling or packagingreason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Code information
Lot: 170320107s; Exp. 01/01/1900
Distribution pattern
Nationwide
drug · product 7 of 7
Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-023-09
